Clinical trials: Surgical Bleeding
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
The EVARREST® Fibrin Sealant Patch Liver Study
To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
- Trial name
- NCT01993888
- Testing
- EVARREST® Fibrin Sealant Patch, Standard of Care (SoC)
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 102 people
- Sponsor
- Ethicon, Inc.
Blood Loss, Surgical
Evaluation of the Quantra System in a Surgical Oncological Population
This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.
- Trial name
- NCT04116385
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- HemoSonics LLC
Operation Site Bleed
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
- Trial name
- Control (NCT00652314)
- Testing
- Thrombi-Gel
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- Vascular Solutions LLC
Von Willebrand Disease (VWD)
A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)
This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor [rVWF]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder.
- Trial name
- NCT06433778
- Testing
- No Intervention
- Where
- 7 sites in United Kingdom
- Volunteers
- 34 people
- Sponsor
- Takeda
Excessive Bleeding During Surgery
A Study of Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Haemostasis During Surgery in Paediatric Participants
The objective of the study is to evaluate if FS Grifols is non-inferior to EVICEL® in terms of the percentage of participants achieving hemostasis at the target bleeding site (TBS) by 4 minutes (T4) from the start of treatment…
- Trial name
- NCT03461406
- Testing
- Fibrin Sealant Grifols, EVICEL
- Where
- 40 sites in United States, Bulgaria and 8 more
- Volunteers
- 186 people
- Sponsor
- Instituto Grifols, S.A.
Surgical Bleeding, Hemorrhage
A Trial of Absorbable Regenerated Oxidized Cellulose for Surgical Hemostasis)
This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial. The purpose is to evaluate the safety and effectiveness of the absorbable multilayer fibrillar regenerated oxidized cellulose…
- Conditions
- Surgical Bleeding, Hemorrhage, Oxidized Regenerated Cellulose
- Trial name
- ZXS2022 (NCT07764055)
- Testing
- Absorbable Multilayer Fibrillar Regenerated Oxidized Cellulose, SURGICEL Absorbable Hemostat (Absorbable Hemostatic Gauze)
- Where
- 6 sites in China
- Volunteers
- 288 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Vascular Anastomosis Surgery
Post-market Clinical Study to Confirm Safety and Performance of PuraStat® for the Management of Bleeding in Vascular Surgery.
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
- Trial name
- NCT03103282
- Testing
- PuraStat®
- Where
- United Kingdom
- Volunteers
- 65 people
- Sponsor
- 3-D Matrix Europe SAS
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Safety and Efficacy of Activated Recombinant Human Factor VII in Haemophilia Patients With Inhibitors During and After Major Surgery
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01561391
- Testing
- activated recombinant human factor VII, factor IX, factor VIII
- Where
- 14 sites in United States
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Postoperative Hemorrhage
A Study of Fibrocaps in Liver Surgery in the Netherlands
A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery.
- Trial name
- NCT01256190
- Testing
- Fibrocaps (fibrin sealant), Gelatin sponge
- Where
- Netherlands
- Volunteers
- 56 people
- Sponsor
- Mallinckrodt
Hematologic Neoplasms, Burns
Hypoxic Red Blood Cells for Burns and Hematological Malignancies at Haukeland University Hospital
The overall objective of this study is to collect preliminary safety data on the transfusion of hypoxic RBCs, manufactured with the Hemanext ONE device, in patients with burns and patients with hematological malignancies.
- Trial name
- NCT05549232
- Testing
- Hypoxic Red Blood Cells
- Where
- Norway
- Volunteers
- 22 people
- Sponsor
- Hemanext
Contraception
Bleeding Pattern Difference Between Levonorgestrel Intrauterine System (LNG-IUS) and Copper Intrauterine Devices (IUDs) Immediately Inserted After Abortion
To observe the bleeding patterns of post-abortion immediate insertion of IUS compared to Cu-IUD over the first 6 months.
- Trial name
- POST (NCT01958684)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028), Copper-IUD
- Where
- China
- Volunteers
- 512 people
- Sponsor
- Bayer
Epiretinal Membrane, Macular Hole
UNITY VCS Vitreoretinal Surgery
This purpose of this study is to compare the safety and effectiveness of two eye surgery systems-UNITY VCS and CONSTELLATION-in treating adults with vitreoretinal diseases or disorders.
- Conditions
- Epiretinal Membrane, Macular Hole, Visually Significant Vitreous Floater, Vitreomacular Traction
- Trial name
- NCT07054281
- Testing
- UNITY Vitreoretinal Cataract System (VCS), CONSTELLATION Vision System, Vitreoretinal ophthalmic surgery
- Where
- 8 sites in United States
- Sponsor
- Alcon Research
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.
Heart Failure
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy
This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.
- Trial name
- PREVENT II (NCT02836652)
- Testing
- HeartMate II (HMII), Warfarin, acetylsalicylic acid (ASA) therapy
- Where
- 35 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Abbott Medical Devices
Hypothermia
Study to Determine the Effects of Pre-warming on OR Patient Temperatures and Surgical Outcomes
The application of active warming to patients whether awake or under general anesthesia has been proven safe in numerous studies and it is common practice to use warmers.
- Trial name
- NCT02177903
- Testing
- Bair Paws Patient Adjustable Warming System
- Where
- Canada
- Volunteers
- 220 people
- Sponsor
- Solventum US LLC
Hemorrhage
SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical…
- Trial name
- NCT03762200
- Testing
- SURGICEL Powder
- Where
- 8 sites in Belgium, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Ethicon, Inc.
Hemorrhage, Surgical, Hemorrhage Postoperative
Safe and Timely Antithrombotic Removal - Direct Oral Anticoagulants Apixaban & Rivaroxaban (STAR-D)
Prospective, Multicenter, Double-blind, Randomized, Study to Evaluate DrugSorb-ATR Removal of Apixaban and Rivaroxaban to Reduce Likelihood of Serious Bleeding in Patients Undergoing Urgent Cardiothoracic Surgery
- Conditions
- Hemorrhage, Surgical, Hemorrhage Postoperative, Blood Loss, Surgical, Blood Loss, Postoperative
- Trial name
- STAR-D (NCT05093504)
- Testing
- DrugSorb-ATR system
- Where
- 27 sites in United States
- Volunteers
- 9 people
- Sponsor
- CytoSorbents, Inc
Cardiovascular, Neurologic (Spine), and General Surgery
A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
- Trial name
- NCT00196534
- Testing
- Human Thrombin, Bovine Thrombin
- Where
- 17 sites in United States
- Volunteers
- 304 people
- Sponsor
- Ethicon, Inc.
Aneurysmal Subarachnoid Hemorrhage
Evaluation of the Efficacy and Safety of Clazosentan in Reversing Cerebral Vasospasm in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to evaluate the safety and potential therapeutic benefit of use of clazosentan in reversing cerebral vasospasm (a narrowing of blood vessels in the brain due to the presence of blood in the space…
- Trial name
- REVERSE (NCT02560532)
- Testing
- Clazosentan
- Where
- 11 sites in Finland, France and 1 more
- Volunteers
- 25 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.