Clinical trials: Hemostasis, Surgical
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
Hemostasis
HEMOBLAST Pivotal Clinical Investigation
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
- Trial name
- NCT02780869
- Testing
- HEMOBLAST Bellows, Absorbable gelatin sponge, USP with thrombin
- Where
- 17 sites in United States
- Volunteers
- 258 people
- Sponsor
- Biom'Up France SAS
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
Hemorrhage
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when…
- Trial name
- NCT03783039
- Testing
- SURGICEL Powder, SURGICEL Original
- Where
- 6 sites in China
- Volunteers
- 234 people
- Sponsor
- Ethicon, LLC
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
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
Hemorrhoids
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids
The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.
- Trial name
- HEMOSTASIS (NCT01306877)
- Testing
- EEA Hemorrhoid and Prolapse Stapling Set, Endosurgery Proximate PPH03 Stapling Set
- Where
- United States
- Volunteers
- 149 people
- Sponsor
- Medtronic - MITG
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
Parapneumonic Effusion, Empyema, Pleural
Treatment of Complicated Parapneumonic Effusion With Fibrinolytic Therapy Versus VATs Decortication
This study aims to standardize the treatment of pleural space (parapneumonic) infections by comparing the difference in outcomes between 2 methods of treatment: early VATS (Video Assisted Thorascopic Surgery) decortication versus…
- Conditions
- Parapneumonic Effusion, Empyema, Pleural, Coagulopathy
- Trial name
- NCT03583931
- Testing
- VATS Decortication, Fibrinolytic Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Denver Health and Hospital Authority
Blood Loss, Surgical
Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study
To examine in Arista hemostatic powder results in less post-total knee arthroplasty blood loss, hematoma formation, and improved range of motion when compared to patients who did not receive the product.
- Trial name
- NCT05522153
- Testing
- Arista
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Acetabulum Fractures
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery.
- Trial name
- TXA (NCT02051686)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- University of Missouri-Columbia
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
Cardiac Surgical Procedures, Hemorrhage
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular…
- Trial name
- NCT01639833
- Testing
- Veriset Hemostatic Patch, TachoSil®
- Where
- 12 sites in Belgium, Germany and 1 more
- Volunteers
- 90 people
- Sponsor
- Medtronic - MITG
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.
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
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
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.
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