Clinical trials: Hemostasis, Surgical
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Surgery
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
- Trial name
- NCT00245336
- Testing
- rThrombin, bovine thrombin
- Where
- 29 sites in United States
- Volunteers
- 401 people
- Sponsor
- ZymoGenetics
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.
Hemorrhage
The Fibrin Pad Liver Study
The objective of this study is to evaluate the safety and and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
- Trial name
- NCT01166243
- Testing
- Fibrin Pad, Standard of Care
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 84 people
- Sponsor
- Ethicon, Inc.
Blood Loss, Surgical
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.
- Trial name
- CLOT (NCT02359994)
- Testing
- PerClot Polysaccharide Hemostatic System, Arista AH
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Artivion Inc.
Haemorrhage, Haemostasis
TachoSil® Versus Standard Haemostatic Treatment of Haemorrhage in Cardiovascular Surgery (TC-023-IM)
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery
- Conditions
- Haemorrhage, Haemostasis, Cardiovascular Surgery
- Trial name
- NCT00440401
- Testing
- fibrinogen (human) + thrombin (human), Standard haemostatic treatment in cardiovascular surgery
- Where
- Denmark
- Volunteers
- 120 people
- Sponsor
- Nycomed
Type A Aortic Dissection
BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients
A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute…
- Trial name
- CHINA (NCT03369977)
- Testing
- BioGlue Surgical Adhesive, Traditional Surgical Repair
- Where
- 7 sites in China
- Volunteers
- 202 people
- Sponsor
- CryoLife, Inc.
Cardiovascular Disease
The Fibrin Pad Cardiovascular Study
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
- Trial name
- NCT01681030
- Testing
- EVARREST™, Topical hemostat, Standard of Care
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- Ethicon, Inc.
Hemostasis
HEMOBLAST Pilot Clinical Investigation
The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting.
- Trial name
- NCT02502019
- Testing
- HEMOBLAST Bellows
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Biom'Up France SAS
Soft Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be present.
- Trial name
- NCT01731938
- Testing
- Fibrin Sealant (FS) Grifols, Surgicel®
- Where
- 25 sites in United States, Hungary and 1 more
- Volunteers
- 327 people
- Sponsor
- Grifols Biologicals, LLC
Soft Tissue Bleeding
The Severe Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic…
- Trial name
- NCT00977925
- Testing
- Fibrin Pad, Standard of Care
- Where
- 17 sites in Australia, Germany and 2 more
- Volunteers
- 91 people
- Sponsor
- Ethicon, Inc.
Target Bleeding Site During Peripheral Vascular Surgery
Safety and Efficacy Study of Fibrin Sealant Grifols Evaluated as an Adjunct to Hemostasis
The purpose of this study is to evaluate the safety and hemostasis effectiveness of human plasma-derived fibrin sealant Grifols (FS Grifols) in peripheral vascular surgery.
- Trial name
- NCT00684047
- Testing
- FS Grifols, Manual Compression
- Where
- 19 sites in Canada, Spain and 1 more
- Volunteers
- 239 people
- Sponsor
- Instituto Grifols, S.A.
Intraoperative Bleeding, Hemorrhage, Surgical
GATT-Patch Versus TachoSil in Liver Surgery
This is a pre-market, prospective, randomized (2:1), multicenter, multi-national pivotal clinical investigation. The purpose of this investigation is to determine the clinical safety and performance of GATT-Patch as compared with…
- Conditions
- Intraoperative Bleeding, Hemorrhage, Surgical, Liver Diseases
- Trial name
- NCT05385952
- Testing
- GATT-Patch (currently named ETHIZIA), TachoSil
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- GATT Technologies BV
Hemostasis, Meningioma Surgery
Phase IV Bioseal Study in Brain Tumor Surgery
The objective of this study is to observe the clinical utility and performance of Bioseal when used as an adjunct to hemostasis versus Standard of Care (SoC) in elective meningioma surgery.
- Trial name
- NCT02034799
- Testing
- Bioseal Fibrin Sealant, Standard of Care (SoC)
- Where
- 7 sites in China
- Volunteers
- 256 people
- Sponsor
- Ethicon, Inc.
Hip Replacement Surgery
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.
- Trial name
- NCT00161902
- Testing
- Fibrin Sealant Vapor-Heated Solvent/Detergent-treated
- Where
- 7 sites in Austria, Germany and 1 more
- Sponsor
- Baxter Healthcare Corporation
Hemostasis
Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
- Trial name
- NCT02014402
- Testing
- Human thrombin, Bovine thrombin
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Instituto Grifols, S.A.
Bleeding
PeproStat as a Topical Agent Used to Stop Bleeding in Patients Undergoing Surgery
The purpose of this study is to test the effectiveness and safety of a new peptide-based coagulant, PeproStat. The study drug will be applied to patients undergoing liver/soft tissue surgery, vascular surgery or spine surgery.
- Trial name
- NCT03131336
- Testing
- PeproStat, Saline
- Where
- 5 sites in Bosnia and Herzegovina, Croatia and 3 more
- Volunteers
- 169 people
- Sponsor
- Haemostatix Ltd
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
Bleeding Disorder, Hypofibrinogenemia; Acquired
Adjusted Fibrinogen Replacement Strategy
The main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate BT524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired…
- Trial name
- AdFIrst (NCT03444324)
- Testing
- BT524, FFP/Cryo
- Where
- 19 sites in Belgium, Czechia and 5 more
- Volunteers
- 222 people
- Sponsor
- Biotest
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Intraoperative Bleeding
Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
This is a prospective, multicenter, randomized, controlled investigation. Subjects in which bleeding from the exposed parenchymal surface is observed intraoperatively following the ligature of vessels visible with the unaided eye…
- Trial name
- BARRIER (NCT01458561)
- Testing
- BioFoam Surgical Matrix, Gelfoam Plus
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- CryoLife, Inc.