Clinical trials: Surgical Hemostasis
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.
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
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.
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.
Acquired Bleeding Disorder, Cardiac Surgery Requiring Cardiopulmonary Bypass
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease
This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary…
- Trial name
- NCT01562574
- Testing
- activated recombinant human factor VII
- Where
- Australia
- Volunteers
- 82 people
- Sponsor
- Novo Nordisk A/S
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.
Bone Metastases
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple…
- Trial name
- NCT00330759
- Testing
- Denosumab, Zoledronic Acid
- Volunteers
- 1,779 people
- Sponsor
- Amgen
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.
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
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
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
Surgical Bleeding
Absorbable Hemostatic Fluid Gelatin Trial
This is a multicenter, single-blind, randomized controlled, non-inferiority trial evaluating the safety and efficacy of an absorbable hemostatic fluid gelatin for surgical hemostasis.
- Trial name
- NCT07830797
- Testing
- Absorbable Hemostatic Fluid Gelatin, Absorbable Hemostatic Fluid Gelatin SURGIFLO Haemostatic Matrix
- Volunteers
- 324 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Nasal Surgery, Hemostasis
Efficacy and Safety of NasoAid® After Nasal Surgery
The goal of this clinical trial is to evaluate the effectiveness and safety of collagen-based absorbable nasal packing (NasoAid®) after nasal surgery.
- Conditions
- Nasal Surgery, Hemostasis, Nasal Packing
- Trial name
- NCT07861061
- Testing
- NasoAid® Intranasal Splint, "Stryker" NasoPore Nasal Dressing
- Where
- 3 sites in Taiwan
- Volunteers
- 154 people
- Sponsor
- Maxigen Biotech Inc.
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.
Hemorrhage, Soft Tissue Bleeding
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
- Trial name
- NCT02227706
- Testing
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Where
- 13 sites in Belgium, Canada and 1 more
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Hemostasis
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.
- Trial name
- NOBLE-Laparo (NCT03873181)
- Testing
- HEMOBLAST™ Bellows
- Where
- 8 sites in Austria, France and 1 more
- Volunteers
- 102 people
- Sponsor
- Biom'Up France SAS
Intra-operative Bleeding
Oxidized Cellulose hEmostAsis evaluatioN
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to…
- Trial name
- OCEAN (NCT01637025)
- Testing
- Oxidized cellulose strip, Oxidized regenerated cellulose strip
- Where
- 24 sites in Czechia, Germany and 2 more
- Volunteers
- 111 people
- Sponsor
- Baxter Healthcare Corporation
Surgical Bleeding
A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery
The primary objective of the study is to demonstrate the non-inferiority or superiority of Fibrocaps plus gelatin sponge compared to Tachosil when control of mild to moderate bleeding with conventional surgical techniques is…
- Trial name
- NCT02284256
- Testing
- Fibrocaps, TachoSil
- Where
- 15 sites in Austria, Germany
- Volunteers
- 150 people
- Sponsor
- Mallinckrodt
C.Surgical Procedure; Cardiac, Haemorrhage.
Safety and Performance of 032-11 Haemostat in Cardiac and Thoracic Aortic Surgery
The effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to Floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.
- Trial name
- NCT01879475
- Testing
- 032-11, Floseal (R)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Medtrade
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