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43 active trials for Hemorrhage

Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean

A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.

Start: March 2018

BiZact Tonsillectomy in the Pediatric Population

This study has been designed to evaluate how effective the Bizact tonsillectomy device is in reducing operating time and complications that occur after surgery. This device operates in a different way than the standard device that is used for most tonsillectomies. In 2019, a study was conducted in 186 children and adults using this device in tonsillectomies. Results showed lower blood loss and shortened time in surgery. However, the rate for bleeding as a complication after surgery was the same as other procedures that are used in tonsillectomy

Start: June 2021

Cold Stored Platelet in Hemorrhagic Shock

The Cold Stored Platelet Early Intervention in Hemorrhagic Shock (CriSP-HS) trial is a proposed 3 year, open label, multi-center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients in hemorrhagic shock. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will utilize 5 level-1 trauma centers from within the LITES network and will enroll approximately 200 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 24 hour mortality.

Start: September 2021

Comparison of 4 Tactical Tourniquets Used in War Medicine

Bleeding remains the leading cause of death in combat, and the literature suggests that tourniquetable hemorrhage is the second leading cause of preventable death, behind non- tourniquetable hemorrhage. Currently, most Western armed forces recommend the use of the tactical tourniquet in combat for the management of tourniquetable hemorrhage. The SOFTT® tourniquet (Tactical Medical Solutions, Anderson) is the tactical tourniquet currently in use by the French armed forces. As the contract will soon come to an end, the question of its renewal arises. The purpose of this study is to compare 4 commercially available tactical tourniquets in healthy volunteers. The hypothesis of the research is that one of the 4 tourniquets compared is faster to set up than the others.

Start: May 2021

The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study

The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.

Start: July 2014

Bentracimab (PB2452) in Ticagrelor-treated Patients With Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure

This is a multi-center, open-label, prospective single-arm study of reversal of the antiplatelet effects of ticagrelor with bentracimab (PB2452) in patients who present with uncontrolled major or life-threatening bleeding or who require urgent surgery or invasive procedure. Approximately 200 patients will be enrolled from approximately 200 centers in North America, Europe, and Asia-Pacific regions, including mainland China. Patients with reported use of ticagrelor within the prior 3 days who require urgent ticagrelor reversal will be eligible for enrollment. These populations will be enrolled based on separate inclusion criteria.

Start: March 2020

Restarting Anticoagulation After Traumatic Intracranial Hemorrhage

Primary Objective: To identify the optimal interval to restart oral anticoagulation after traumatic intracranial hemorrhage that will minimize thrombotic events and major bleeding by performing a response adaptive randomized (RAR) PROBE clinical trial of restarting in anticoagulant-associated traumatic intracranial hemorrhage patients, comparing restart at 1 week to restart at 2 weeks or at 4 weeks, with a primary composite outcome of major thrombotic events and bleeding. Primary Outcome: 60-day composite of thromboembolic events, defined as DVT, pulmonary emboli, myocardial infarctions, ischemic strokes and systemic emboli, and bleeding events defined as non-CNS major bleeding events (modified BARC3 or above) and worsening index tICrH or new intracranial hemorrhage (ICrH). Secondary objectives of this trial include: To use the Trauma Quality Improvement Program (TQIP) of the American College of Surgeons - Committee on Trauma (ACS-COT), a well-established and highly respected trauma center oversight mechanism, to translate findings of the trial into practice in a closed loop. To establish a relationship between time of restarting and overall secondary events, i.e. a dose response, that favors early restarting (1 week is better than 2 weeks and 2 weeks is better than 4 weeks. To explore patient centered utility weighting of thrombotic versus bleeding composite endpoint components by: A) 60-day Disability Rating Scale (DRS) 24,25 and modified Rankin Scale (mRS)26; B) Trial patient-reported standard gamble utilities including by race, gender and ethnicity. To explore the composite without DVT in the thrombotic component

Start: October 2021

Feasibility of Evaluating XSTAT Use in the Prehospital Setting

This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.

Start: July 2021

Prehospital Transfusion Strategy in Bleeding Patients

The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion. A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only Hypothesis: Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit). Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

Start: May 2021

CNAP vs IABP in Pregnant Women With Placenta Accreta

The objective of this study is to investigate a technique to monitor blood pressure in women undergoing cesarean delivery with suspected placenta accreta spectrum. To achieve this objective, the investigators plan to conduct a prospective, observational study with the following aims: Specific Aim 1: Compare concordance between the systolic (SBP), diastolic (DBP), and mean arterial blood pressure (MAP) readings from the continuous non-invasive arterial blood pressure (CNAP) and IABP at several discrete points throughout the procedure Specific Aim 2: Determine the feasibility of using CNAP to aid in decision making by examining the parameters of volume responsiveness and arterial elastance at several discrete points throughout the procedure. The investigators hypothesize that the investigators can obtain similar blood pressure monitoring using CNAP as compared to the gold standard IABP in women undergoing cesarean delivery with suspected placenta accreta.

Start: January 2021

Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes in Women Undergoing Dilation and Evacuation

Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.

Start: July 2021

A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients

The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.

Start: November 2014

Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Ketamine

The purpose of this project is to test how ketamine, an analgesics currently employed in the pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in humans.

Start: June 2018

A 48 Subject Study Using Non-invasive Multi-Technology Measurements for Early Detection of Ongoing Hemorrhage

Early detection of ongoing hemorrhage (OH) before onset of hemorrhagic shock is a universally acknowledged great unmet need, and particularly important after traumatic injury. Delays in the detection of OH are associated with a "failure to rescue" and a dramatic deterioration in prognosis once the onset of clinically frank shock has occurred. An early alert to the presence of OH would save countless lives. This is a single site study, enrolling 48 patients undergoing liver resection in a "no significant risk" prospective clinical trial to: 1) further identify a minimal subset of noninvasive measurement technologies necessary for the desired diagnostic performance, 2) validate the performance of our Phase I algorithm, and 3) re-train the algorithm to a Phase II human iteration. The main outcome variables are non-invasive measurements that will be used for machine learning, not real-time patient management. The data generated will be used later for discovery and validation in traditional and innovative machine learning.

Start: March 2021

A Comparison of Volatile Anesthesia and Total Intravenous Anesthesia (TIVA)

In this study, investigators wanted to investigate the effect of volatile anesthesia and total intravenous anesthesia (TIVA) on ecchymosis, edema, and intraoperative bleeding in rhinoplasty.

Start: March 2021

The Cryopreserved vs. Liquid Platelets Trial

This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.

Start: May 2021

The Effect of Non-invasive Hemoglobin Measurement in Hip Surgeries

Bleeding is one of the most important causes of mortality and morbidity in patients. Hb levels are the most prevalently utilized monitoring parameter in hemorrhagic patients in the hemodynamic sense. Hemoglobin determination is studied at laboratories along with blood gasses or complete blood analysis. Recently, non-invasive techniques where measurement is made from the fingertips have been offered for use. One of these techniques is non-invasive hemoglobin (SpHb) measurement. SpHb is used as a trend monitor. Based on the severity of bleeding, the compensatory mechanisms of patients may be disrupted. This situation may lead to lower levels of toleration of anemia during bleeding. The relationship between blood transfusion and mortality is under debate.

Start: January 2021

NOACs in Oral and Maxillofacial Surgery: Impact on Post-operative Complications

Aims: To investigate the incidence of bleeding complications during oral surgical procedures in patients medicated with DOACs. To investigate the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs. To examine whether increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time. Previous studies have shown that the incidence of healthcare-consuming bleeding complications following oral surgical procedures in patients who are prescribed warfarin is approximately 4% (9). To investigate whether the incidence is higher or lower by the intake of DOAC it is considered to be sufficient with 100 patients in each group. The groups consist of patients who are prescribed warfarin, DOACs, as well as a control group. Hypothetical outcomes: The incidence of bleeding complications and the perioperative and postoperative bleeding volume during oral surgical procedures in patients medicated with DOACs are higher compared to patients medicated with warfarin and patients taking no anticoagulants. Increased perioperative bleeding volume complicates the planned intervention, thereby prolonging the operation time. Clinical relevance: The study will serve as a basis for the development of treatment guidelines for patients who medicate with DOACs. If it turns out that the oral surgery procedure presents no increased risk of complications and that the bleeding volume does not complicate the surgery significantly, it may be recommended that patients who medicate with DOACs whom are in need of oral surgical procedures seek ordinary dental care.

Start: June 2016

Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

Start: July 2018

TRial to EvaluAte Tranexamic Acid Therapy in Thrombocytopenia

The purpose of this study is to test whether giving tranexamic acid to patients receiving treatment for blood cancers reduces the risk of bleeding or death, and the need for platelet transfusions. Patients will be randomised to receive tranexamic acid (given intravenously through a drip, or orally) or a placebo.

Start: June 2015