Clinical trials: Surgical Hemostasis
Peripheral Vascular Disease, Hemorrhage
The Evicel Post-Authorization Surveillance Study
The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.
- Trial name
- NCT01158261
- Testing
- EVICEL ™ Fibrin Sealant (Human)
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Ethicon, Inc.
Coronary Artery Bypass Graft, Cardiopulmonary Bypass
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of…
- Trial name
- NCT01535222
- Testing
- MDCO-2010
- Volunteers
- 32 people
- Sponsor
- The Medicines Company
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
Lobectomy, Segmentectomy
MicroCutter Assisted Thoracic Surgery Hemostasis Registry
The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures.
- Trial name
- MATCH (NCT02816671)
- Testing
- Surgical Stapler
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- AesDex, LLC
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
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
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
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, 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.
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
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.
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.
Reversal of Coagulopathy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring
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.
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
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
FS VH S/D 500 S-apr in Vascular Surgery
The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.
- Trial name
- NCT00892957
- Testing
- Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Surgical gauze pads
- Where
- 22 sites in United States
- Volunteers
- 176 people
- Sponsor
- Baxter Healthcare Corporation