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.

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.

TOP-CABG Trial: Follow-up Extension (TOP-CABG FE)

To further evaluate the long-term effects of the two antiplatelet strategies on saphenous vein graft patency, long-term adverse cardiovascular events, and bleeding events after coronary artery bypass grafting (CABG), we plan to conduct an extended follow-up study based on the previously completed TOP-CABG trial. This extended follow-up aims to provide high-quality evidence to inform more optimized and individualized long-term antiplatelet management strategies for patients after CABG.

The Efficacy of Lavender Herbal Tea in Premenstrual Syndrome

Premenstrual syndrome (PMS) is a common but complex condition defined as a combination of emotional, psychological, and physical symptoms that occur during the luteal phase of the menstrual cycle, usually between 2 and 14 days before the onset of menstruation, and that diminish with menstruation. Epidemiological studies have reported that 80-90% of women experience premenstrual syndrome symptoms, with approximately 20-40% reported to affect daily functioning and relationships. Symptoms associated with PMS include irritability, mood swings, anxiety, depression, bloating, breast tenderness, and headaches. Pharmacological treatments such as selective serotonin reuptake inhibitors (SSRIs) and non-pharmacological methods such as dietary changes, exercise, and cognitive behavioral therapy are used in the management of PMS symptoms. Complementary herbal therapies are gaining increasing interest among individuals who want to avoid the side effects of traditional pharmacological agents. Various agents such as Vitex agnus-castus (chaste tree), Hypericum perforatum (St John's wort), evening primrose oil, and conventional herbal formulations have been studied in the literature. Vitex agnus-castus was found to be effective in relieving PMS symptoms by regulating hormonal balance. The antidepressant effects of yellow cantharone have been evaluated, but findings on its efficacy are inconsistent. Evening primrose oil shows particularly favorable effects on cyclic mastalgia. Lavender tea is known to reduce depression, anxiety, and mood swings. There are no clinical studies evaluating the effect of lavender tea on menstrual bleeding. A randomized controlled trial has shown that abdominal massage with lavender oil reduces the severity of menstrual pain. In this context, it may be a potential complementary herbal treatment to relieve PMS symptoms. Therefore, women with PMS will be divided into two groups. The intervention group will use 2 grams of lavender tea 2 times a day, morning and evening, for 9 days during 2 menstrual cycles (5 days before and 4 days after the estimated onset of menstruation). The control group will create a waiting list. The study data will be provided by 'Personal Information Form', 'Premenstrual Syndrome Scale', 'Depression Anxiety Stress-21 Scale', 'Premenstrual Syndrome Specific Quality of Life Scale', Visual Analogue Scale (VAS), and pad follow-up to monitor bleeding. SPSS 25.0 software will be used to analyze the data obtained from the study. Although the effects of lavender tea on PMS are promising, more clinical studies are needed to confirm its effectiveness. With this study, the need for clinical studies on the effectiveness of lavender tea will be met and a natural and complementary treatment method that can alleviate PMS symptoms will be tested.

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

Autologous Cold-stored Apheresis Platelets

The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design. The recent introduction of cold-stored platelets with a shelf-life of 14 days into clinical practice has made it possible to offer autologous apheresis platelet predonation to patients undergoing elective cardiac (and other high-blood-loss) surgeries while allowing sufficient time to recover platelet count before surgery. The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the healthcare system by reducing the burden on allogeneic platelet supply. The study is also designed to determine whether patients are willing to donate autologous platelets 7-10 days prior to surgery.

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.

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.

Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding

This randomized clinical trial will enroll patients at National Cheng Kung University Hospital who have upper gastrointestinal ulcer bleeding, have undergone endoscopic hemostasis, and have a Rockall score of 6 or higher. A total of 108 patients will be enrolled and randomly assigned to two groups: Standard-treatment group: 54 patients, Experimental group: 54 patients. Both groups will receive standard endoscopic hemostasis and 72 hours of intravenous PPI therapy. Thereafter, patients in the standard-treatment group will receive double-dose PPI therapy, whereas patients in the experimental group will receive a P-CAB per day. All patients will be followed for 28 days to assess the occurrence of rebleeding.

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.

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.

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.

Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor

Assessment of high-normal dosage of Wilate ® compared to placebo administered in combination with platelets to assess reduction of amount of blood loss, need of transfusion products and outcome (length of stay, mortality) in patients with bleeding in comparison.

Colibricare Efficacy on Oral Surgical Procedures/Extraction Wound and Gingiva Retraction

In this randomized, three-arm trial, 120 patients undergoing wisdoms' extractions were assigned to control (gauze pressure application), commercial sponge, or Coli-sorb® groups. Outcomes included time to hemostasis, ease of placement, pain (VAS), facial swelling, and wound healing, assessed on days 1, 7, and 6 weeks.

Stannous Fluoride Toothpaste for Reduction and Treatment of Gingivitis

This study evaluated the efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste in reducing gingivitis, bleeding, and plaque over a 12-week period. A total of 132 subjects were randomized to one of two treatment groups and assessed at baseline and at Weeks 2, 4, 8, and 12 using standardized clinical indices, including the Modified Gingival Index (MGI), Bleeding Index (BI), and Plaque Index (PI).

This Study Aims to Assess the Impact of 50°C Saline Irrigation on the Overall Intraoperative Blood Loss and Surgical Visualization During Endoscopic Sinus Surgery for Rhinosinusitis.

Objectives: Intraoperative bleeding during endoscopic sinus surgery for severe rhinosinusitis may significantly compromise the surgical field. Saline heated to 50°C promotes transient vessel vasodilation and mucosal edema without causing nasal mucosal necrosis. The brief thermal exposure may induce superficial protein denaturation and facilitate local hemostasis, thereby improving endoscopic visibility. This study aims to assess the impact of 50°C saline irrigation on the overall intraoperative blood loss and surgical visualization during endoscopic sinus surgery for rhinosinusitis. Methods: This prospective randomized controlled trial study is going to assign the patients to three groups. In the interventional hot saline group (HSI), intraoperative irrigation will be performed with heated saline at 50°C. In the room-temperature saline group (RTSI), saline at 22°C will be used; in the third one group (Control), no irrigation will be administered. Intraoperative blood loss will be recorded in milliliters and milliliters per minute of operative time, and the surgical field will be evaluated using the Boezaart scale. HSI is hypothesized to be more effective than RTSI in minimizing intraoperative bleeding during FESS.

Preoperative Tranexamic Acid (TXA) to Prevent Bleeding in Patients Undergoing Major Colorectal Surgery

The goal of this prospective pragmatic randomized clinical trial is to determine if preoperative administration of tranexamic acid (TXA) reduces bleeding during and after major colorectal surgery. The primary questions are: * Does TXA reduce bleeding during and after surgery (change in hemoglobin from before surgery to lowest value after surgery within 30 days) * Does TXA reduce bleeding complications within 30 days of surgery (blood transfusion, return to the operating room or procedural intervention for bleeding, death due to bleeding) * Does TXA increase the risk of thromboembolic complications within 30 days of surgery (cerebrovascular accident, myocardial infarction, deep venous thrombosis, pulmonary embolism) Researchers will compare preoperative TXA to no TXA to answer the above questions. Participants who receive TXA will receive 1 g TXA IV at the beginning and end of surgery in the operating room.

Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)

While the reduced hemorrhagic risk of radial access for percutaneous coronary intervention compared to femoral access is well-established, its main complication remains radial artery occlusion, which can occur in up to 30% of patients. Anticoagulation is the primary preventive measure recommended in clinical practice to reduce the risk of this complication, typically involving heparin injection during the procedure in most centers. However, data on the effect of the timing of heparin injection are limited. The investigators hypothesize that injection of heparin before sheath insertion may reduce the rate of radial artery occlusion compared with injection after sheath insertion.

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.

How Bleeding Affects Delirium in Older Patients With Hip Fractures: The IMPROVE-HIP Study

The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is: Do patients aged 75 and older with hip fractures benefit from earlier treatment of anemia (low blood count) to reduce the risk of delirium? Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium. Participants will: Undergo blood tests, have their vital signs monitored, and be screened for delirium three times a day for the first 48 hours after surgery. Receive blood transfusions promptly if their hemoglobin levels fall below a specified threshold. Attend a follow-up visit at 30 days to assess cognitive function and overall quality of life. Attend another follow-up at 90 days to evaluate hospital readmissions and survival.

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation

This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs. Rivaroxaban (A novel oral anticoagulant) in patients with new onset atrial fibrillation after sternotomy for cardiac operations.

Evaluation of the Postoperative Agitation Prevention and Analgesic Efficacy of Perioperative Dexmedetomidine Infusion in a Pediatric Patient Group to Undergo Tonsillectomy and Adenoidectomy

Dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. The purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. In the research, laboratory and monitoring results will be obtained before, during and after the operation. Postoperative patient complaints will be evaluated at the postoperative service visit. This study is decided on a completely voluntary basis.

Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

As bleeding is a major risk in bariatric surgeries, The study aimed to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.