Clinical trials: Hemostasis, Surgical
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
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.
Rectal Cancer Stage III, Lung Cancer Stage III
Bovine Reinforcement in Stomach, Colorectal and Lung Operation
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of stomach,colorectal and lung anastomoses reinforced with a bioabsorbable staple line reinforcement material…
- Trial name
- NCT06968221
- Testing
- Bioabsorbable Staple Line Reinforcemen
- Where
- China
- Volunteers
- 172 people
- Sponsor
- Shanghai Cingularbio Co. Ltd
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.
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.
Blood Loss, Surgical
QStat in Liver Transplant
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
- Trial name
- NCT04114253
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
Blood Loss, Surgical
HemoSonics - UTMB Cardiac Surgery Study
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the…
- Trial name
- NCT03988465
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
Blood Loss, Surgical
Observational Cohort Study of TachoSil (TC-018-IN)
The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding.
- Trial name
- NCT00285623
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 3,000 people
- Sponsor
- Nycomed
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.
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
Spinal Surgery, Vascular Surgery
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
- Trial name
- NCT00491608
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- ZymoGenetics
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
Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
Fibrin Sealant Vascular Surgery Study
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants…
- Trial name
- NCT00576420
- Testing
- FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time, Manual compression with surgical gauze pads
- Where
- 11 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Surgical Hemostasis
Safety and Efficacy of Topical Recombinant Human Thrombin(rhThrombin) for Surgical Hemostasis
A multicenter, stratified randomized, double-blind, placebo-controlled, phase 3 clinical trial.
- Trial name
- NCT04459871
- Testing
- recombinant human Thrombin(CHO cell)
- Where
- China
- Volunteers
- 348 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Bleeding
ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered.
- Trial name
- NCT02264730
- Testing
- ClotFoam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Biomedica Management Corporation
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
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
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.
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
Blood Loss, Surgical
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
- Trial name
- NCT00813904
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- ZymoGenetics