Clinical Research Directory

Biological and Clinical Relevance of Quantra Viscoelastic Hemostatic Assay in Hemorrhagic Cardiac Surgery

The goal of this observational study is to assess the correlation between Quantra viscoelastometric assay and laboratory hemostasis biology in a cardiac surgery cohort presenting with acute hemorrhage in the operating room. The main questions it aims to answer are: * is Quantra a valuable surrogate for hemostasis biology in the setting of bleeding cardiac surgery? * are Quantra parameters well correlated with tranfusion thresholds in the setting of bleeding cardiac surgery?

NIRS Monitoring in Premature Infants

This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment. This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.

CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial

The CAlcium and VAsopressin following Injury Early Resuscitation (CAVALIER) Trial is a proposed 4 year, double-blind, mutli-center, prehospital and early in hospital phase randomized trial designed to determine the efficacy and safety of prehospital calcium and early in hospital vasopressin in patients at risk of hemorrhagic shock.

Onyx™ Liquid Embolic IDE Clinical Study

The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.

Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation

Atrial fibrillation (AF) is the most common arrhythmia, significantly increasing the risk of stroke, heart failure, hospitalization and death in patients. Studies have shown that standardized anticoagulation can effectively reduce the risk of stroke by 64% and the risk of death by 26% in AF patients. Therefore, both European and American guidelines recommend standardized oral anticoagulation (OAC) as an important treatment strategy for stroke prevention in AF patients. However, the use of OAC may also increase the risk of bleeding in patients. Results from large AF anticoagulation randomized trials show that the annual risk of anticoagulation-related bleeding mortality is 2% to 3%. Therefore, according to the guidelines recommendations, assessing the bleeding risk is necessary in patients with anticoagulant indications. Percutaneous left atrial appendage occlusion (LAAO) is a device-based therapy that aims to prevent ischemic stroke in patients with AF. For patients with contraindications to long-term anticoagulation therapy, LAAO can be considered as an alternative strategy to oral anticoagulation (Class II B recommendation) to prevent ischemic stroke and thromboembolism. Multiple studies have shown that LAAO is non-inferior to warfarin and novel oral anticoagulants in stroke prevention for non-valvular AF patients. Age is not only a risk factor for stroke but also an important risk factor for bleeding. In the elderly population, especially those with frailty, the risk factors for both stroke and bleeding are often increased. Currently, there is insufficient evidence to support the use of OAC in frail elderly patients with relative anticoagulant contraindications. Therefore, elderly AF patients may be one of the potential beneficiary groups for LAAO. However, most previous clinical studies on LAAO were based on small sample sizes to analyze their safety and efficacy, and clinical data on the safety and efficacy of LAAO in this high-risk population of elderly AF patients are still limited. To address this, the study aims to conduct a multicenter randomized controlled trial to compare the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients with high bleeding risk, filling the gap in this research area. To address these limitations, this multicenter randomized controlled trial is designed to evaluate the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients at high risk for bleeding. The primary objective of the study is to compare the 12-month incidence and time-to-occurrence of the composite clinical endpoint. This endpoint includes stroke/TIA, systemic embolism, ISTH-defined major bleeding. By establishing these metrics within the first year, the study aims to fill the current void in clinical evidence and provide a standardized treatment strategy for high-risk elderly patients. In addition to the primary endpoints, the study will conduct a comprehensive long-term evaluation extending to 24 months post-procedure to assess the durability of both treatment strategies. Secondary objectives include the assessment of perioperative safety, specifically focusing on serious intraoperative complications and major adverse events occurring within the first seven days after the LAAO procedure. The trial will also measure long-term rhythm control by tracking the rate of freedom from AF recurrence at the one-year and two-year marks. Furthermore, the study seeks to verify the hypothesized superiority of the ablation-plus-LAAO strategy in reducing the specific burden of anticoagulation-related major bleeding and stroke. Beyond clinical safety and efficacy, the trial will analyze the practical aspects of the two interventions, including procedural success rates, operation duration, fluoroscopy time, and the total duration of hospitalization. A critical component of the research involves identifying specific risk factors associated with complications, with a specialized focus on how frailty scores influence procedural tolerance and long-term prognosis. The study will further explore how different types of AF respond to the LAAO strategy and assess the impact of each treatment on non-major bleeding events. Ultimately, the trial aims to determine which strategy offers a superior improvement in the overall quality of life for elderly patients, thereby optimizing future clinical guidelines.

Oral Hygiene and Prophylactic Antibiotics to Prevent Intracerebral Hemorrhage Associated Pneumonia

Project Name: Randomized Controlled Clinical Study on oral hygiene and prophylactic antibiotics to prevent Intracerebral Hemorrhage associated pneumonia Research Objectives: To evaluate the effectiveness, safety and health economics value of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 1. To clarify the effectiveness of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 2. To clarify the safety of enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. 3. To clarify the health economics value of low-intensity enhanced oral hygiene combined with antibiotics in preventing post-cerebral hemorrhage pneumonia. Research Design: Research Type: Multicenter, Randomized, Controlled, Open Label, Blinded Endpoint Research Design Research Hypothesis: Intensive oral hygiene combined with antibiotic treatment is beneficial in reducing the incidence of pulmonary infections related to cerebral hemorrhage.

Efficacy of Prehospital Tourniquet Models for Arterial Occlusion in Upper and Lower Limbs

The goal of this clinical trial is to compare the occlusive capability and mechanical behavior of different commercially available pre-hospital tourniquet models and the results of their application on upper and lower limbs, in order to validate the techniques proposed in international guidelines regarding proximal application on the arm and thigh ("high and tight tourniquet") and controlled application, 2 to 3 inches proximally to the injury, on the forearm and leg ("controlled tourniquet"). It is estimated that 40 volunteer individuals will be recruited, who will sign the Informed Consent Form (ICF), a group primarily composed of undergraduate and graduate students in health-related fields. Regarding inclusion and exclusion criteria, these individuals will be of both sexes, aged ≥18 and ≤60 years, with both upper and lower limbs, a Body Mass Index (BMI) ≥18.5 and ≤30 kg/m² (considering the normal and overweight range, excluding underweight and obesity ranges), and without Diabetes Mellitus (DM), Systemic Arterial Hypertension, Buerger's disease, vascular and metabolic dysfunctions affecting the limbs including lymphedema, history of neoplasms, cardiac surgeries, renal failure, recent open or closed injuries in the limbs, or any other condition suggestive of systemic or localized vascular dysfunction in the limbs. The main questions it aims to answer are: Null Hypothesis (H0): There are no significant differences in the occlusive capability between TQs and in the efficacy of total vascular occlusion (arteriovenous) depending on the application site among the segments (forearm, arm, leg, thigh). Alternative Hypothesis (H1): There are significant differences in the occlusive capability between TQs and in the efficacy of total vascular occlusion (arteriovenous) depending on the application site among the segments (forearm, arm, leg, thigh). Specific Hypothesis: TQs will present significant variations in initial tightening pressures, arterial occlusion times, and arterial occlusion pressures, evidencing differences that may affect their efficacy. Each participant will receive a total of 8 TQ applications on the arm, forearm, leg, and thigh segments bilaterally, for each of the 3 non-consecutive collection days. Vascular occlusion will be verified using Doppler ultrasound on the radial artery for upper limbs and on the posterior tibial artery for lower limbs. It is a cross-sectional and self-controlled trial, aimed at collecting primary data, with randomization of the application order regarding device, laterality, segment, and blinding of the statistical analyst regarding the applied tourniquet model.

Traumatic Injury Clinical Trial Evaluating Tranexamic Acid in Children: An Efficacy Study

Trauma is the leading cause of death and disability in children in the United States. The objective of this study is to evaluate the benefits and harms of tranexamic acid (TXA; a drug that stops bleeding) in severely injured children with hemorrhagic brain and/or torso injuries. Using thromboelastography, we will measure baseline fibrinolysis to assess for treatment effects of TXA at different levels of fibrinolysis.

Evaluation of the Impact of an Expert Opinion During the Management of Patients With Severe Bleeding on Oral Anticoagulants.

The goal of this randomized clinical trial is to evaluate the impact of an expert opinion during the management of patients with severe bleeding on oral anticoagulants. The main question it aims to answer is : • Does an expert help of decision during the management of patients with severe bleeding is superior to classic management ? The centers will be randomized in one of the two groups : control group and interventional group. Patients will be followed for 3 months. At their inclusion they will be managed in conformity of the randomisation of their center. They will be followed at hour 0 + 6 , H0+24 and at the end of hospitalization. After 3 months, they will be called to assess the occurrence of thrombotic events ou hemorrhage complications. Researchers will compare the classic management versus the management with an expert opinion to see if the expert opinion is superior to classic management.

Comparative Effectiveness of INTERCEPT Fibrinogen Complex (IFC) and Cryoprecipitate-AHF (Cryo-AHF) for Treatment of Trauma Associated Hemorrhage

The objective of this study is to determine the feasibility and effectiveness of early IFC administration in patients with functional hypofibrinogenemia associated with hemorrhagic shock (HS). This study will elucidate whether advancements in rapid testing for functional hypofibrinogenemia and provision of a shelf-stable fibrinogen complex (IFC) results in a shorter time to administration of fibrinogen replacement, thus overcoming the limitations encountered by prior trials. This study aims to: * Demonstrate the feasibility and response to early administration of pre-thawed IFC compared to CRYO-AHF when ordered during resuscitation of severely injured patients with HS and functional hypofibrinogenemia. * Assess effectiveness of early administration of pre-thawed IFC vs CRYO-AHF in severely injured patients with HS and functional hypofibrinogenemia on proximate process measures of resuscitation. * Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC vs CRYO-AHF product.

Consortium for Optimized Integration of Bio-Artificial Blood Components for Adaptive Resuscitation Therapy

There is need for a whole blood analog for use when banked blood is unavailable or undesirable. In civilian trauma, hemorrhage accounts for \~ 35% of pre-hospital deaths; moreover, \~ 20% of military casualties are in hemorrhagic shock on arrival to field hospitals and an additional 5% require urgent transfusion. A recent review concluded that hemorrhage accounted for \~ 90% of potentially survivable battlefield deaths - lives that could be saved with better hemorrhage control capabilities and improved, field-ready blood, blood components, or blood substitutes. While study of ideal composition for resuscitative fluids is ongoing, it is evident that for those in hemorrhagic shock, volume replenishment alone (without O2 carrying capacity) is insufficient. Alternatively, with massive blood loss or with ongoing bleeding from non-compressible injuries, resuscitation with an O2 carrier alone may be complicated by acquired coagulopathy (either dilutional or trauma-induced). Development of a balanced resuscitation fluid that treats both shock and coagulopathy (comprising a field-deployable O2 carrier with lyophilized humoral hemostatic components and platelets) is essential to allow on-scene treatment during the critical 'golden-hours' after injury. As such, the whole blood analog described herein could be this product, thus transforming care in both civilian and military settings.The scientific purpose of this study is to develop a combined whole blood substitute from individual artificial prototypes that have been separately developed for each blood component (i.e., combining an artificial oxygen carrier, with an artificial plasma analogue and an artificial platelet analogue). Together, these combined components will recapitulate the composition and performance of natural whole blood. Blending and combination experiments of the individual artificial prototypes will be performed to test compatibility and optimize efficacy. State of the art in vitro (bench top) assays will be performed to assess physicochemical and functional performance (hemodynamics, oxygen delivery, hemostasis), with data being compared to experiments performed on fresh and stored whole blood.

Evaluation of Transthoracic Echocardiography Parameters and Their Changes in Blood Donor Volunteers

This study investigates the impact of blood donation on transthoracic echocardiography (TTE) parameters in healthy volunteers, aiming to enhance the understanding of hemodynamic changes associated with mild blood loss and assess non-invasive monitoring techniques for early hemorrhage detection. Conducted as a prospective, interventional study with minimal risk, this research is designed to simulate a controlled hemorrhage in a civilian setting, using voluntary blood donation as a model to study the physiological effects of blood loss of approximately 6 mL/kg. Rationale and Background Hemorrhagic shock is a leading cause of preventable death in trauma patients, particularly among younger populations. The ability to rapidly detect and quantify blood loss is crucial in trauma management, as delayed or excessive resuscitation can lead to adverse outcomes, including multi-organ failure and coagulopathy. Traditional methods of monitoring blood volume and cardiac output, such as invasive catheterization or imaging techniques like CT scans, may not be feasible or practical in prehospital settings. TTE, particularly the measurement of the aortic time-velocity integral (TVI) using Doppler echocardiography, presents a non-invasive and potentially valuable tool for assessing cardiac output and detecting early hemodynamic changes due to blood loss. Primary Objective The primary objective of this study is to evaluate whether the aortic TVI decreases by at least 10% following a controlled blood volume reduction during blood donation. This decrease in TVI could serve as a reliable marker of reduced cardiac output and might allow clinicians to detect mild to moderate blood loss in trauma patients non-invasively. Secondary Objectives The study also aims to examine additional echocardiographic parameters that may indicate changes in hemodynamic status following blood loss. Secondary objectives include measuring changes in: Shock index (SI), calculated as the ratio of heart rate to systolic blood pressure, a parameter often associated with hypovolemia. E-wave and e'-wave velocities, which reflect left ventricular filling pressures and diastolic function. Ratios of E/e' and E/A, which are indicative of left ventricular diastolic function and filling pressures. Global longitudinal strain of the left ventricle (GLS), which represents myocardial contractility. Methods Healthy adult volunteers meeting eligibility criteria for blood donation are recruited from local blood donation centers. Participants undergo baseline TTE to measure the aortic TVI, E-wave, e'-wave, and other relevant parameters before donation. Following a blood donation procedure of approximately 450 mL (representing a 6 mL/kg blood loss for the average volunteer), TTE is repeated immediately after donation and then 15 minutes post-donation to capture any transient changes in cardiac output and ventricular function. Volunteers receive structured hydration and are observed for any adverse events. Outcome Measures The primary outcome measure is a decrease of at least 10% in aortic TVI from baseline immediately following blood donation, which would confirm the sensitivity of TTE to detect mild hypovolemia. Secondary outcome measures include changes in the shock index, variations in Doppler-derived E and e' waves, and the E/e' and E/A ratios, assessed immediately and 15 minutes post-donation. The study will also monitor the global longitudinal strain (GLS) as an additional measure of left ventricular performance. Statistical Analysis The required sample size was calculated to detect a 10% decrease in TVI with 90% power at a 5% significance level, resulting in a target enrollment of 66 participants. Descriptive statistics will be used for continuous variables, expressed as mean ± standard deviation or median and interquartile range as appropriate. Paired t-tests or Wilcoxon signed-rank tests will assess changes in parameters before and after blood donation. Each participant's response will be classified as positive if a decrease of at least 10% in TVI is observed, or negative if the decrease is below this threshold. Potential Impact If successful, this study could validate the use of TTE-derived parameters, such as aortic TVI and shock index, as non-invasive markers for early detection of blood loss in trauma patients. By providing real-time insight into hemodynamic changes, this approach could improve decision-making in prehospital and emergency settings, allowing clinicians to tailor resuscitation strategies based on the actual volume of blood loss. This could reduce the risks associated with both under-resuscitation and over-resuscitation, ultimately improving patient outcomes.

A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.

Hemodynamic Monitoring During Craniosynostosis Surgery: Comparing Traditional and Newer Technology Monitors (CRASY-PRAM)

Hemodynamic evaluation during pediatric anesthesia is essential to care management. Intraoperative cardiovascular instability is frequent in major surgeries, and appropriate monitoring is necessary to ensure safe anesthetic conduction and promptly detect changes in blood pressure, cardiac output, blood volume, and organ perfusion. In this context, advanced hemodynamic monitoring, continuous measuring, and estimating various parameters can allow a more specific hemodynamic profile and help identify the causal mechanisms of its variability. Moreover, the reference ranges of hemodynamic values in different pediatric ages and how to best monitor hemodynamic status in pediatrics are still debated. Surgical treatment of craniosynostosis is usually performed at an early age, between 3 and 8 months of age. The operation is burdened by a high risk of hemodynamic instability related mainly, but not only, to potential substantial hemorrhagic losses. This study aims to characterize the hemodynamic events occurring during corrective craniosynostosis surgery, recorded simultaneously with standard monitoring and Pressure Recording Analytic Method (PRAM), and to analyze the paired measurements.

Effectiveness of the Pressure Recording Analytical Method in Predicting Fluid Responsiveness in Pediatric Critical Care Patients

The Pressure Recording Analytical Method, invasive hemodynamic monitoring, is an uncalibrated pulse contour analysis, installed in the Mostcare® system that allows a continuous estimation of the stroke volume and thus the cardiac output, by the relationship between the area under the curve of the systolic portion of the arterial blood pressure curve and the dynamic impedance of the cardiovascular system. The objectives of the study are to determine if the parameters measured by Mostcare® make it possible to predict the response to volume expansion in pediatric surgical critical care patients, sedated, intubated and ventilated, by comparing the changes in stroke volume, induced by a volume expansion, measured by trans-thoracic echocardiography.

Topical and Local TXA in Facelifts - A Randomized Controlled Double Blinded Study

Tranexamic acid (TXA) is a fibrinolytic inhibitor which prevents prolonged bleeding by interfering with fibrin clot breakdown by competitively binding to lysine receptors on plasminogen; this prevents the conversion of plasminogen to plasmin. TXA will be applied to a randomly assigned side of the face during facelift surgery. The intervention groups will include 1% TXA mixed with standard local consisting 1/4% lidocaine with 1:100,000 epinephrine, 3% TXA on TXA-soaked pledgets applied for 10 minutes, and 1% TXA with local plus 3% TXA-soaked pledgets. Each treatment arm will be compared to saline in place of TXA on the contralateral side of the face. Although TXA has been widely used in surgical fields for decades and is officially recommended by agencies such as ACOG for use during maternal hemorrhage, its current FDA approval only pertains to oral TXA for heavy menstrual bleeding and IV use for patients with hemophilia to prevent or reduce hemorrhage (cite). The main concern with intravenous TXA is the increased risk for the potential formation of blood clots, mainly in patients with clotting disorders, such as Facor V Leiden, and patients on estrogen containing medication. A recent systemic review with metanalysis by Wang et.al contained a total of 2150 patients receiving IV TXA while undergoing plastic surgery concluded that use of IV TXA does not lead to increased adverse events.\[12\] Given the low rate of adverse events while using TXA systemically, this protocol's application of TXA topically and/or locally negates the risk for any potential systemic adverse effects. No systemic adverse effects have been reported in studies examining local TXA in facial plastic surgery to date.

Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock

This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A/B IgM titer \< 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.

Pre-hospital Ventilation Clinical Study

This study will collect and characterize ventilator use during patient care with a ZOLL 731 Series ventilator in a pre-hospital setting.

Q Therapeutic System for Chronic Stroke Recovery

Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes

Although procedural abortion in the second trimester is extremely safe, hemorrhage is one of the leading causes of morbidity and mortality. Tranexamic acid (TXA) is used commonly in obstetrics to prevent or manage intrapartum or postpartum hemorrhage and has been associated with decreased mortality and decreased blood loss at the time of birth. Some guidelines are recommending the use of TXA for both the prevention and management of bleeding for abortion care. However, there are currently no published studies assessing the association between TXA and bleeding outcomes for abortion procedures. This study will involve a randomized, placebo-controlled trial of pregnant patients aged 18 and older desiring dilation and evacuation (D\&E) for abortion or fetal demise at 18-24 weeks gestation. The primary aim is to determine whether prophylactic TXA has an effect on the need for additional interventions to control bleeding at the time of D\&E. The secondary aim is to determine whether prophylactic TXA has an effect on the mean quantitative procedural blood loss.

Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery

The goal of this clinical trial is to learn if tranexamic acid (TXA) helps reduce bleeding during bariatric surgery, such as laparoscopic sleeve gastrectomy (LSG) and mini gastric bypass (MGB). It will also look at how safe TXA is for people undergoing these procedures. The main questions it aims to answer are: Does TXA reduce the amount of blood loss during bariatric surgery? Are there any side effects or complications in patients who receive TXA? Researchers will compare TXA to standard care (no TXA) to see if it is effective in reducing bleeding. Participants will: Receive either TXA or no TXA (placebo) before surgery Undergo standard bariatric surgery (LSG or MGB) Have their blood loss, hemoglobin levels, and any complications monitored during and after surgery

REpeated ASSEssment of SurvivorS in Intracerebral Hemorrhage Study

The investigators propose to perform serial detailed cognitive, motor, behavioral, and blood collection follow-up using longitudinal structured telephone interviews of an anticipated 350 ICH survivors enrolled in Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation (MISTIE) III and ENRICH trials to identify specific cognitive and motor impairment and to perform RNA sequencing to evaluate for evidence of chronic inflammation. The investigators' expected sample size in 2022 accounts for mortality attrition of 10%/year.

U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.

This pilot study aims to assess performance, safety and feasibility of U-CaVIT method (Uro-Catheter Vacuum Induced Tamponade), using the Rüsch® Brillant Silicone Balloon Catheter, an urological catheter, for the prevention of atonic PPH in high-risk women undergoing cesarean delivery. The U-CaVIT method has been implemented at the Department of Obstetrics at university hospital of Zurich (USZ) due to temporary supply issues with the Bakri® Balloon Catheter. The Rüsch® Balloon Catheter is used in case of uterine atony when standard first-line uterotonic treatments have failed or in some cases as add-on therapy in non-atonic PPH. In the meantime, the use of U-CaVIT has become standard practice at the USZ for the treatment of atonic PPH, appearing to be user-friendly, clinically effective according to treating physicians, well tolerated by the treated women and cost-saving compared to the previously used Bakri® Balloon.

SWIFT - SWIss Factor XIII Trial in PPH

The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH). Summary of current body of evidence: * Morbidity and mortality due to PPH is rising. * Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials. * Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss. Therefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII. All participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \[MBL\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.