Clinical Research Directory

CHAMPION-AF Clinical Trial

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure

The objective of the study is to compare short-term (8 weeks) anticoagulation therapy (DOAC) vs. antiplatelet therapy for the prevention of device thrombosis following transcatheter LAAC.

Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial

The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo.

The Effects of Intraoperative Tranexamic Acid on Perioperative Bleeding In Craniotomies

The goal of this clinical trial is to test the effect of a drug called tranexamic acid (TXA) on reducing blood loss in participants undergoing surgery to remove brain tumors. The main questions it aims to answer are: 1. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA reduce the amount of estimated blood loss during surgery? 2. Does TXA 20 mg/kg IV bolus of TXA, and 1 mg/kg/hr infusion of TXA prevent re-operation, disability or death related to bleeding inside the head during and after surgery? Participants are randomized to receive 20 mg/kg IV bolus of TXA or matching placebo within 30 minutes of start of surger, and then 1 mg/kg/hr infusion of TXA or matching from the start of surgery to end of surgery. Treatment allocation is blinded. Investigator will compare the two treatment arms to see whether there are differences in the amount of blood loss during surgery and bleeding-related complications. Investigators will also monitor for any side effects of TXA.

SIMPLAAFY Clinical Trial

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

SWITCH: Apixaban vs Vitamin K in HM3

This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.

Concomitant PFA Bsaed PVI Plus LAAC

A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific). For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.

Factor VIII Inhibitor Bypass Activity (FEIBA) Versus Fresh Frozen Plasma As First Line Therapy For Bleeding After Cardiac Surgery

Coagulopathic-induced bleeding after cardiopulmonary bypass in cardiac surgery patients is common and is associated with adverse outcomes in cardiac surgery. The hypothesis of the study is that FEIBA will be a more effective treatment than standard of care (FFP) in cardiac surgery patients who have coagulopathic-induced bleeding. This study is being conducted to determine the efficacy of FEIBA versus FFP as first line therapy in correcting coagulopathic induced microvascular bleeding in cardiac surgery patients.

Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device

Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events. This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.

BAR-TAX - Tranexamic Acid in Bariatric Surgery.

Perioperative bleeding is a relevant complication in bariatric surgery and may lead to hemoglobin decrease, blood transfusions, reinterventions, prolonged hospital stay, and increased healthcare costs. Tranexamic acid (TXA), an antifibrinolytic agent, has demonstrated efficacy in reducing surgical bleeding in several surgical specialties, with a favorable safety profile when appropriately used. However, evidence in bariatric surgery remains limited, particularly considering the intrinsically increased thromboembolic risk of obese patients. The BAR-TAX study is a prospective, single-center study conducted in a high-volume bariatric surgery center, aiming to evaluate the efficacy and safety of perioperative TXA administration compared with standard care without TXA. The primary objective is to assess whether TXA reduces the incidence of clinically significant bleeding within 48-72 hours after bariatric surgery. Secondary objectives include evaluation of hemoglobin drop, transfusion rates, need for hemostatic procedures or reoperation, thromboembolic events, postoperative complications, length of hospital stay, readmissions, and TXA-related adverse events.

Amplatzer Amulet LAAO vs. NOAC

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Safety of Perioperative Anticoagulation Management in People With Active Cancer Undergoing Cancer-Related Surgery or Procedures (ACE-HIGH Study)

The purpose of this study is to help find how safe current practices are when managing blood thinners in people with cancer who are having surgery or medical procedures. Investigators will also measure how often bleeding or clotting problems happen in this setting. The goal is to use this information to improve future care and reduce these risks for patients. This study will determine whether contemporary practices can be safely applied to cancer patients, and also evaluate the blood thinner level left over in patient's body at the time of surgery.

Incidence of Bleeding, Thrombosis and Transfusion Requirements in ICU Patients With COVID-19 Supported With Veno-venous Extracorporeal Membrane Oxygenation

The investigators aim to assess the risk of bleeding and thrombo-embolic complications as well as benefit and harm of blood product transfusion and anticoagulation therapy in adult ICU patients with COVID-19 supported with V-V ECMO

Bleeding Management İn Open Heart Surgery

This study aims to develop an algorithm that can guide targeted bleeding management through thromboelastography (TEG) viscoelastic testing performed on blood samples from patients undergoing open heart surgery. The goal is to develop an algorithm that supports targeted bleeding management based on TEG parameters. The study is prospective, in vitro, and non-invasive. The material will consist of residual blood samples from open heart surgery patients. Analyses will be performed using TEG parameters (R time, K time, MA, LY30). Patients will be randomized using a closed-envelope method and divided into two groups: anesthesiologist standard clinical observation-control (Group K) and anesthesiologist standard clinical observation and TEG analysis (Group T). The sample size is 70 patients per group. From an ethical standpoint, this study uses anonymous data without additional blood collection and ensures patient safety.

Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery.

The goal of this retrospective clinical trial is to find out association antiplatelet and anticoagulant therapy with perioperative complications in non-cardiac vascular surgery in patients . The main questions it aims to answer are: Does the use of antiplatelet agents and anticoagulants affect the development of complications in the perioperative period during operations on the main arteries? Does discontinuing antiplatelet and anticoagulant medications affect the development of perioperative complications in major artery surgeries?? Researchers will compare with patients who didn't use antiplatelets and anticoagulant drugs to see ift he incidence of complications comparable? This is a retrospective study based on the analysis of medical records (case histories).

The Feasibility, Safety, and Efficacy of EUS-Guided PSE: A Cohort Study

Bleeding from esophagogastric varices in patients with liver cirrhosis is often life-threatening. Thrombocytopenia caused by hypersplenism secondary to portal hypertension is an independent risk factor for such gastrointestinal bleeding. Studies have confirmed that partial splenic embolization (PSE) can effectively reduce portal pressure and decrease the risk of rebleeding. Traditional treatments mainly include total splenectomy and X-ray-guided transarterial partial splenic embolization (X-PSE). Although total splenectomy can completely remove the lesion, its application is limited by issues such as increased risks of postoperative infection, thrombosis, and long-term immune dysfunction. Currently, X-PSE has become the mainstream treatment. This technique involves superselective catheterization of the splenic artery branches using a microcatheter and injecting embolic microspheres to achieve partial splenic embolization, thereby preserving partial splenic function. However, X-PSE relies on radiological intervention techniques and carries risks such as radiation exposure, contrast-induced nephropathy, and non-target embolization (e.g., pancreatic necrosis). Additionally, its ability to locate small arterial branches in the splenic hilum is limited. Endoscopic ultrasound (EUS) integrates an ultrasound probe at the tip of an endoscope, enabling high-resolution imaging and fine-needle aspiration therapy of the pancreas, gastrointestinal tract, posterior mediastinum, and retroperitoneal structures. With color Doppler functionality, EUS can clearly identify abdominal vessels and their blood flow signals. Since the spleen and splenic vessels are located posterior to the gastric fundus, EUS can clearly visualize the vascular structures of the splenic hilum via a transgastric approach. Compared to X-PSE, EUS-guided PSE offers the following advantages: a shorter puncture path; avoidance of iodinated contrast agents, making it suitable for patients with iodine allergies or renal insufficiency; no X-ray exposure for patients or operators; the ability to combine treatment for esophagogastric varices in the same procedure, thereby simplifying the process, reducing costs, and shortening hospital stays; and, since there is no arterial puncture site on the body surface, patients do not require prolonged limb immobilization postoperatively, resulting in an overall better healthcare experience. Current literature and small-sample retrospective studies have reported on this technique, but the included cases are mostly limited to patients with mild liver function impairment, and there is a lack of systematic evaluation of its effect on portal pressure reduction. The investigators' center integrates the advantages of EUS and X-PSE to perform EUS-guided transgastric puncture for precise injection of embolic materials into the splenic artery branches in patients with liver cirrhosis, gastrointestinal bleeding, and hypersplenism, achieving partial splenic embolization. This study aims to evaluate the safety and efficacy of EUS-guided PSE. The primary endpoint is safety, including the incidence of complications such as intraoperative bleeding, postoperative fever, and abdominal pain scores. Secondary endpoints include efficacy indicators: platelet count, portal pressure gradient, embolization area on CT, incidence of gastrointestinal rebleeding, as well as hospitalization costs and length of stay.

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG

The primary objective of this study is to evaluate the effectiveness (prevention of thromboembolic events) and safety (major bleeding) of adding oral anticoagulation (OAC) to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation (POAF) after isolated coronary artery bypass graft (CABG) surgery. All patients with a qualifying POAF event, who decline randomization, will be offered the option of enrollment in a parallel registry that captures their baseline risk profile and their treatment strategy in terms of anticoagulants or antiplatelets received. These patients will also be asked to fill out a brief decliner survey.

Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs

This study looks at patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. In many hospitals, surgery for these patients is delayed because of concerns about bleeding, but waiting longer can also increase risks such as complications and longer hospital stays. The purpose of this study is to find out whether operating within 24 hours is as safe as delaying surgery beyond 24 hours. Specifically, the investigators want to know if early surgery does not lead to a higher need for blood transfusions compared to delayed surgery.

Delayed Cold-Stored Platelets -PLTS-1

PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.

Aspirin in Reducing Events in the Elderly-Extension (ASPREE-XT)

ASPREE-XT is a post-treatment, longitudinal observational follow-up study of ASPREE participants. Although the ASPREE trial medication was ceased, the study activity was not stopped and ASPREE participants are continuing with scheduled visits and phone calls. An observational follow-up phase (ASPREE-XT), began in January, 2018. This will enable the monitoring of possible delayed effects of aspirin treatment, primarily on cancer incidence, metastases and mortality. In addition to monitoring the incidence of malignancy within the ASPREE cohort, the opportunity will be taken to observe any other residual effects of aspirin on the endpoints being monitored in the cohort. Continuity of contact with study participants is the key to retention of the cohort for any ongoing or future studies.

Impact of IV Iron on Bleeding Symptoms in Iron Deficient Patients With Inherited Bleeding Disorders

This is a prospective, single-arm, single-center observational study evaluating the impact of intravenous (IV) iron replacement in patients with inherited bleeding disorders and iron deficiency (ferritin \<50ng/dL). Subjects will undergo baseline bleeding assessments, quality-of-life measures, and laboratory tests before receiving standard-of-care IV iron. Follow-up blood work and questionnaires will be conducted post-replacement to assess for changes

Amulet™ ADVANCE LAA

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding

This research conducted by EMBOBIO SAS is intended for patients with bleeding or at risk of bleeding in the abdominal-pelvic region requiring embolization. The EmboBio device (embolization implant) is a Class IIb medical device that is not CE marked (meaning that it is not yet commercially available on the European market). The objective of the study is to demonstrate the safety and performance of the EmboBio medical embolization device in humans in order to obtain CE marking, the European authorization required for the commercialization of medical devices. Safety will be assessed by collecting data on events that may be related to the device, and the device will be considered effective if the target arteries are completely occluded (blocked) at the end of the operation. The plan is to include 45 patients (men and women aged 18 or over who have given their consent to participate in the study) requiring embolization in the abdominal-pelvic region in French hospitals over a period of 12 months. The patient's full participation is requested for a period of approximately 6 months.

Intravenous Tranexamic Acid

Tranexamic acid is a promising option for minimizing blood loss in high-risk bariatric surgery patients, particularly in those with obesity, diabetes, and other comorbidities. When used appropriately, TXA can reduce the need for blood transfusions, maintain hemodynamic stability, and lower the incidence of complications related to blood loss.