Clinical trials: Surgical Bleeding
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Hemorrhage, Urgent Surgery
Bentracimab in Ticagrelor-treated Patients With Uncontrolled 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…
- Conditions
- Hemorrhage, Urgent Surgery, Invasive Procedure
- Trial name
- REVERSE-IT (NCT04286438)
- Testing
- Bentracimab (PB2452) Infusion
- Where
- 68 sites in United States, Austria and 11 more
- Volunteers
- 226 people
- Sponsor
- SFJ Pharmaceuticals, Inc.
Hypovolaemia Due to Acute Blood Loss
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective abdominal surgery.
- Trial name
- PHOENICS (NCT03278548)
- Testing
- Volulyte 6%, Ionolyte
- Where
- 61 sites in Austria, Belgium and 8 more
- Volunteers
- 2,289 people
- Sponsor
- Fresenius Kabi
Blood Loss, Surgical, Blood Loss, Postoperative
Comparative Study Between Preoperative and Postoperative Rectal Misoprostol
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise…
- Trial name
- NCT06049160
- Testing
- Misoprostol
- Where
- Egypt
- Volunteers
- 128 people
- Sponsor
- Egymedicalpedia
Hemorrhage
Non-Interventional Study About Treatment of Hemorrhages in Thyroid Surgery With TachoSil®
Considering the total number of thyroid procedures in Germany (100000 - 120000 cases per year), TachoSil® is a valuable tool to support surgical haemostasis, avoiding lymph leaks and support speech-nerve saving approaches.
- Trial name
- NCT00700141
- Where
- 132 sites in Germany
- Volunteers
- 482 people
- Sponsor
- Nycomed
Cancer, Venous Thromboembolism
CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)
The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e.
- Trial name
- NCT00219973
- Testing
- Bemiparin
- Where
- 4 sites in Portugal, Romania and 2 more
- Volunteers
- 526 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
Control of Local Bleeding in Patients Undergoing Prostatectomy.
Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)
The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy.
- Trial name
- NCT00290836
- Testing
- Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)
- Where
- Denmark
- Volunteers
- 120 people
- Sponsor
- Nycomed
Bleeding, Surgical Wound
Traumacel PULVIS and Traumacel ENDO Applicator in the Post-market Surveillance Phase
Traumacel PULVIS is a sterile absorbable haemostatic plant polysaccharide powder made of the oxidized cellulose. Traumacel PULVIS is designed to stop capillary bleeding as well as to prevent bleeding in the early post-operative…
- Trial name
- NCT05177887
- Testing
- Traumacel PULVIS, Traumacel ENDO Applicator
- Where
- Czechia
- Volunteers
- 100 people
- Sponsor
- Bioster, a.s.
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Safety of rFXIII in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to evaluate the safety of escalating single doses of rFXIII (recombinant factor XIII, catridecacog) administered following first…
- Trial name
- NCT02239146
- Testing
- catridecacog
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 43 people
- Sponsor
- Novo Nordisk A/S
Cardiovascular Disease
Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy Volunteers
The objectives of this study are to look at the safety and tolerability of the experimental drug, how people process the drug, how the drug affects people, and to identify a dose or doses to study in subsequent future studies.
- Trial name
- NCT00099450
- Testing
- INS50589 Intravenous Infusion
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery
This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01579968
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 86 people
- Sponsor
- Novo Nordisk A/S
Hemorrhage
CU Programme of Idarucizumab for Japanese Patients
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when…
- Trial name
- NCT02831660
- Testing
- idarucizumab
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Blood Loss, Surgical
Observational Cohort Study of TachoSil (TC-018-IN)
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
- Trial name
- NCT00285623
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Nycomed
Bleeding
Phase II Study to Compare MDCO-2010 vs Placebo and Tranexamic Acid in Patients Undergoing Cardiac Surgery
The objective of this study is to determine the dose response relationship regarding blood loss, PK, PD and clinical outcomes of MDCO-2010 in comparison to placebo and tranexamic acid in patients undergoing primary cardiac…
- Trial name
- NCT01530399
- Testing
- MDCO 1, MDCO 2, MDCO 3
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 44 people
- Sponsor
- The Medicines Company
Mild or Moderate Surgical Bleeding
A Study of Fibrocaps™ in Surgical Bleeding
The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis.
- Trial name
- FINISH-3 (NCT01527357)
- Testing
- Fibrocaps, Gelatin sponge
- Where
- 48 sites in United States, Belgium and 2 more
- Volunteers
- 721 people
- Sponsor
- Mallinckrodt
Anemia, Blood Loss, Surgical
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Trial name
- NCT00264095
- Testing
- Oncological surgery
- Where
- 11 sites in Netherlands
- Volunteers
- 488 people
- Sponsor
- Janssen-Cilag B.V.
Surgical Hemorrhage
A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that…
- Trial name
- NCT07824024
- Testing
- Hemofence, Floseal hemostatic matrix
- Where
- 3 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- BMI Korea
Hemorrhage
This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in…
- Trial name
- NCT03343704
- Testing
- Idarucizumab
- Where
- 13 sites in China
- Volunteers
- 19 people
- Sponsor
- Boehringer Ingelheim