Clinical Research Directory

Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis

This randomized, double-blinded controlled trial evaluates whether lidocaine with adrenaline reduces bruising (ecchymosis) more effectively than lidocaine without adrenaline among women undergoing contraceptive implant insertion or removal at King Chulalongkorn Memorial Hospital. Bruising is common after these procedures and may contribute to stigma and concealment behaviors; adrenaline's vasoconstrictive effect may lessen bleeding, prolong anesthesia, and reduce bruising, but the two formulations have not been directly compared in this setting. A total of 450 women aged ≥18 years will be enrolled and randomized 1:1 (sealed opaque envelopes) to receive either lidocaine with adrenaline or lidocaine without adrenaline during implant insertion or removal. Participants and outcome assessors will be blinded. During the procedure, blood loss, heart rate, blood pressure, and pain will be recorded. Post-procedure follow-up lasts 7 days: participants submit standardized photos of the procedure site via Line OA on Day 3 and Day 7 for bruise assessment and report pain onset and satisfaction with wound appearance/healing. Risks include transient effects potentially related to adrenaline (e.g., restlessness, palpitations, flushing, dizziness, brief increases in heart rate or blood pressure) and typical minor procedure-related effects (pain, mild bleeding, temporary discomfort). Vital signs will be monitored before and up to 30 minutes after anesthetic administration. Photo submission carries minimal privacy risk; images and data will be coded and stored securely with access limited to authorized personnel. If an adverse event is related to study participation and instructions were followed, medical costs and reasonable loss-of-time compensation will be covered. No insurance is provided. No direct benefit to participants is expected, but findings may improve clinical practice by reducing bruising and enhancing patient satisfaction with contraceptive implant services. Participation is voluntary; withdrawal is permitted at any time without affecting medical care. Collected data will be anonymized; investigators, the sponsor, and authorized ethics/regulatory bodies may review records as permitted by law. Data will be destroyed after study completion; no biological samples will be stored. Principal investigator contact: Assoc. Prof. Somsook Santibenchakul, MD, PhD, MPH, Department of Obstetrics and Gynecology, King Chulalongkorn Memorial Hospital, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand; dr.somsook@gmail.com * Ethics inquiries: Research Ethics Committee, Faculty of Medicine, Chulalongkorn University, Ananda Mahidol Building, 3rd Floor, King Chulalongkorn Memorial Hospital, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand; +66 2 256 4493; medchulairb@chula.ac.th

DEPOSITION - Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

The aim is to conduct a double-dummy multi-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TxA) versus the usual intravenous TxA in patients undergoing on-pump cardiac surgery.

Cold Stored Whole Blood in Cardiothoracic Surgery

In vitro platelet function and post-transfusion platelet recovery of platelets stored in whole blood decline during storage. In this pilot randomized clinical trial we aim to investigate the impact of storage time of whole blood on the effect and safety in treatment of immediate blood loss in patients undergoing complex cardiothoracic surgery. The study is designed as an exploratory superiority study to support feasibility and provide critical guidance for future, more definitive randomized trials. In the study the test group will receive CPD whole blood leukocyte-depleted with a platelet-sparing filter and stored for 15-21 days whereas the control group patients will receive leukocyte-depleted CPD whole blood stored for less than 7 days.

Corona Mortis in Patients Undergoing TEP for Inguinal Hernia

This study aim to describe the presence, type and size of Corona mortis (CMOR) in patients undergoing total extraperitoneal (TEP) inguinal hernia repair procedures. This study also aim to describe the preperitoneal vascular anatomy of inguinal area and provide in vivo knowledge about CMOR.

Effect of Prophylactic Fibrinogen Concentrate In Scoliosis Surgery

EFISS is a prospective, randomized, placebo-controlled trial testing the feasibility, safety and efficacy of prophylactic administration of fibrinogen in paediatric spinal surgery. The study is monocentric and will be conducted in University Hospital Brno, Czech Republic. This is a pilot study in which the primary objective will be to evaluate the feasibility of a clinical trial in 32 selected patients undergoing scoliosis surgery. Participants will be randomized into study groups in a 1:1 allocation ratio and followed up for 28 days after surgery. The expected duration of this clinical trial is 8 months.

Tranexamic Acid to Reduce Contraceptive-related Bleeding Side Effects

This randomized double blinded trial seeks to determine whether tranexamic acid (TXA) is an efficacious treatment for contraceptive induced menstrual changes (CIMC) including irregular, bothersome bleeding caused by the etonogestrel subdermal contraceptive implant (ENG implant). Participants will be randomized into the TXA treatment arm or a placebo. They will begin taking the medication after three consecutive days of bleeding. Participants will track their bleeding using an automated text message service

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.

AI Assistance for Detecting Active Bleeding During DSA Procedures

Clinically, DSA-VDet can continuously indicate suspected bleeding regions throughout a complete angiographic sequence and provide a second-reader opinion to the operator. It is expected to reduce the time required for frame-by-frame review and localization of culprit vessels, reduce missed detection of small, multiple, or unusually located bleeding sites, and improve consistency among physicians with different levels of experience. Faster culprit-vessel localization may also reduce repeat angiography, radiation exposure, and unnecessary superselective catheterization. These potential benefits will be tested in the prospective randomized trial; the study does not assume that the model will necessarily improve clinical outcomes. From a translational perspective, the study will establish a standardized temporal DSA database spanning multiple centers, devices, and anatomical regions, together with bleeding-site annotation standards, a model suitable for real-time deployment, and a pathway for clinical evaluation. These resources may provide a reproducible technical foundation for regional collaboration in emergency interventional care and AI-assisted interpretation in lower-resource hospitals. The core value of this study is therefore to address the 'single-region, weak-temporal, algorithm-centered, clinically under-evaluated' limitations of existing models. Using multicenter DSA videos from multiple anatomical regions, the study will leverage contrast kinetics and motion information to improve detection of small bleeding sites and will progress from retrospective validation through controlled physician interpretation to a prospective randomized trial, providing a continuous evaluation from technical performance to clinical benefit.

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.

Comparison of Clopidogrel-based Antiplatelet Agent Treatment and Aspirin Plus Low Dose Rivaroxaban Therapy

The study aims to conduct a randomized controlled trial among adults aged 19 years or older who have experienced acute myocardial infarction at least one year prior, or who have other comorbidities such as peripheral arterial disease or multiple cardiovascular diseases, and have consented to participate in the study. Participants will be randomly assigned to either a group that maintains antiplatelet therapy with aspirin and clopidogrel or clopidogrel alone, or a group that maintains combined antiplatelet and anticoagulant therapy with aspirin and low-dose rivaroxaban in a 1:1 ratio. The study aims to demonstrate that maintaining clopidogrel-based antiplatelet therapy is not clinically inferior to maintaining combined therapy with aspirin and low-dose rivaroxaban.

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.

Postoperative Care After Tonsillectomy

Tonsillectomy is one of the most common surgical procedures performed on both pediatric and adult patients; it is frequently associated with significant postoperative pain, difficulty swallowing, and the risk of complications such as bleeding and infection. The recovery period requires care aimed at minimizing discomfort, promoting healing, and preventing adverse events. Metabolic demands increase postoperatively due to surgical stress and the tissue repair process. Adequate nutrition, with a focus on protein intake, is fundamental for the synthesis of new proteins, the repair of injured tissues, and the maintenance of immune function-all essential for rapid, effective recovery and the prevention of complications. Insufficient protein intake can compromise surgical wound healing and the immune response. Additionally, the integrity and hydration of the oropharyngeal mucosa are crucial following a tonsillectomy. Surgical trauma and exposure to ambient air (especially after anesthesia and intubation) can lead to mucosal dryness, pain, discomfort, and scab formation, potentially hindering healing and increasing the risk of secondary infections. Micronebulization with saline solutions emerges as a potential intervention to hydrate the mucosa, alleviate discomfort, and promote the healing process. Despite the recognized importance of nutrition and local humidification, evidence regarding the combined impact of protein supplementation strategies and the use of micronebulizers on the recovery of patients undergoing tonsillectomy-specifically within a randomized clinical trial-requires further investigation. This study aims to contribute to the evidence base by evaluating the efficacy of these combined interventions on relevant clinical outcomes.

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.

STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump

This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to the standard antithrombotic regimen of vitamin K antagonist combined with aspirin in terms of safety and efficacy.

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.

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.