Clinical trials: Hemostasis, Surgical
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
Hypofibrinogenemia, Afibrinogenemia
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
- Conditions
- Hypofibrinogenemia, Afibrinogenemia, Bleeding Disorders
- Trial name
- RiaSTAP (NCT02822599)
- Testing
- RiaStAP, Saline
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Knee Replacement Surgery, Osteoarthritis
Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty
The purpose of this study is to compare the efficacy and safety of FLOSEAL to standard of care for hemostasis in subjects undergoing total knee arthroplasty.
- Trial name
- NCT01410240
- Testing
- Standard of Care, FLOSEAL Hemostatic Matrix + Standard of care
- Where
- 12 sites in United States
- Volunteers
- 137 people
- Sponsor
- Baxter Healthcare Corporation
Congenital Heart Disease
Fibrinogen Concentrate vs Cryoprecipitate
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and…
- Trial name
- NCT03014700
- Testing
- Fibrinogen Concentrate, Cryoprecipitate
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Stanford University
Bleeding
Comparison of Efficacy and Safety of TachoSil® Versus Surgicel® Original for the Secondary Hemostatic Treatment of Needle Hole Bleeding in Vascular Surgery
Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and…
- Trial name
- VASUS (NCT01500135)
- Testing
- TachoSil®, Surgicel® Original
- Where
- 37 sites in United States
- Volunteers
- 150 people
- Sponsor
- Takeda
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
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.
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
Bladder Cancer, Hemostasis
Radical Cystectomy: Can We Improve Our Surgical Technique With the Ligasure Impact Tissue-Sealing Device?
Evaluate the utility/safety of an FDA-approved tissue sealing device during radical cystectomy as compared to an FDA-approved stapling device.
- Trial name
- NCT00802633
- Testing
- Stapling device during radical cystectomy, Ligasure tissue sealing device
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Vanderbilt University
Seroma
Arista for ALT Donor Sites to Reduce Drain Output
This is a single-blinded multi-institutional randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc.
- Trial name
- NCT02477774
- Testing
- ARISTA
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Blood Loss
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery
The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery.
- Trial name
- NCT00990288
- Testing
- Hemostatic Matrix
- Where
- United States
- Volunteers
- 196 people
- Sponsor
- Hospital for Special Surgery, New York
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.
Bleeding, Hemorrhage
Protamine in Cardiac Surgery and Haemostasis
Protamine is used after Cardiopulmonary Bypass (CPB) to reverse the anticoagulant effects of heparin and restore coagulation. Convincing evidence from in-vitro and in-vivo studies suggest that an overdose of protamine has…
- Trial name
- PROTT (NCT01608971)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Heart and Diabetes Center North-Rhine Westfalia
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
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
Hemorrhage, Soft Tissue Bleeding
EVARREST™ Fibrin Sealant Patch Post-Market Study
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and…
- Trial name
- EVARREST (NCT01902459)
- Testing
- EVARREST™ Fibrin Sealant Patch, Standard of Care
- Where
- United States
- Volunteers
- 150 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
Coagulopathy
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce allogeneic blood product use and decrease unnecessary laboratory costs.
- Trial name
- TOP-CLOT (NCT02540434)
- Testing
- ROTEM, Cryoprecipitate, RiaSTAP
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Weill Medical College of Cornell University
Valvular Heart Surgery
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
This non-inferiority, randomized controlled trial aims to evaluate whether coagulation-guided low-dose four-factor prothrombin complex concentrate (PCC) is non-inferior to fresh frozen plasma (FFP) in reducing cumulative chest…
- Trial name
- NCT04244981
- Testing
- Prothrombin Complex Concentrate, Human, Fresh Frozen Plasma
- Where
- 2 sites in China
- Volunteers
- 476 people
- Sponsor
- SHI Jia
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.