Clinical trials: Hemostasis, Surgical
Postoperative Hemorrhage
U.S. Study of Fibrocaps in Surgical Hemostasis
The purpose of this study was to characterize the safety and hemostatic activity of topical Fibrocaps in surgical patients when control of mild to moderate bleeding by standard surgical techniques was ineffective and/or…
- Trial name
- NCT01256164
- Testing
- Fibrocaps (fibrin sealant), Gelfoam
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Mallinckrodt
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.
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.
Cardiovascular Bleeding, Vascular Bleeding
The Bioseal Vascular Study
To evaluate the clinical utility of Bioseal as an adjunct to control bleeding during elective vascular surgery.
- Conditions
- Cardiovascular Bleeding, Vascular Bleeding, Hemorrhage
- Trial name
- NCT02094885
- Testing
- Bioseal Fibrin Sealant, Manual Compression
- Where
- 9 sites in China
- Volunteers
- 252 people
- Sponsor
- Ethicon, Inc.
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
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.
Parenchymous Tissue Surgical Bleeding
Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries
This study is designed to assess the safety and efficacy of Fibrin Sealant Grifols in patients undergoing open surgical procedures where bleeding may be present on parenchymous tissue (e.g., solid abdominal organs such as the…
- Trial name
- NCT01754480
- Testing
- Fibrin Sealant Grifols, Surgicel®
- Where
- 33 sites in United States, Hungary and 2 more
- Volunteers
- 325 people
- Sponsor
- Instituto Grifols, S.A.
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Heart Valve Disease, Coronary Artery Disease
RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen.
- Trial name
- RiaCT (NCT01283321)
- Testing
- Human fibrinogen concentrate, apheresis platelets
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Emory University
Congenital Bleeding Disorder, Haemophilia A
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
- Trial name
- pathfinder™3 (NCT01489111)
- Testing
- turoctocog alfa pegol
- Where
- 70 sites in United States, Australia and 19 more
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
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
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Cardiovascular Disease
The Fibrin Pad CV Phase III Study
The objective of this study is to evaluate the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch as an adjunct to hemostasis during cardiovascular surgery.
- Trial name
- NCT02040428
- Testing
- EVARREST™ Fibrin Sealant Patch, Topical hemostat
- Where
- 24 sites in United States, Australia and 3 more
- Volunteers
- 156 people
- Sponsor
- Ethicon, Inc.
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
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