Clinical trials: Hemostasis
Hemostasis
Post-market Evaluation of HEMOBLAST™ Bellows in Spine Surgery
Prospective, multi-center, multi-national post-market study evaluating the performance and safety HEMOBLAST™ Bellows in spine surgery
- Trial name
- NCT04471350
- Testing
- HEMOBLAST™ Bellows
- Where
- France
- Sponsor
- Biom'Up France SAS
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
Hemostasis, Bleeding
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.
- Trial name
- NCT03654560
- Testing
- HemoStyp, Surgicel
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- United Health Products, Inc.
Hemostasis
A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
- Trial name
- NCT03896061
- Testing
- Laparoscopic sleeve procedures
- Where
- 3 sites in United States
- Volunteers
- 62 people
- Sponsor
- Ethicon, Inc.
Hemostasis Monitoring
Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications
- Trial name
- NCT03679286
- Testing
- PCM and ROTEM
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Entegrion, Inc.
Adjunct to Hemostasis During Vascular Surgery
Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis
The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm…
- Trial name
- NCT04083807
- Testing
- TISSEEL Lyo, Manual compression with surgical gauze pads
- Where
- 5 sites in Russia
- Volunteers
- 104 people
- Sponsor
- Baxter Healthcare Corporation
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
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
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.
Contraception, Liver Metabolism
"E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"
The proposed study will provide an assessment of the effect of this combination on endocrine function, metabolic control and hemostasis during 6 treatment cycles. This will be compared to the effects of two reference COCs.
- Conditions
- Contraception, Liver Metabolism, Hemostasis Parameter
- Trial name
- NCT02957630
- Testing
- 15 mg E4/3 mg DRSP, 30 mcg EE/150 mcg LNG, 20 mcg EE/3 mg DRSP
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Estetra
The Patients Who Needed Hemostasis at the Puncture Site of Common Femoral Artety(CFA) Caused by Femoral Angiogram or Intervention After the Catheter Removal
Effectiveness and Safety Confirmation Between FASTSEAL® Bioabsorbable VCD and Perclose® ProGlide SMC System
It is purposed to verify a superiority of the Fastseal® Bioabsorbable Vascular Access Closure System through effectiveness and safety confirmation of hemostasis (TTH; Time to hemstasis) and ambulation (TTA; Time to ambulation) at…
- Trial name
- NCT01597570
- Testing
- Vascular Closure Device
- Where
- 2 sites in South Korea
- Volunteers
- 52 people
- Sponsor
- Taewoong Medical Co., Ltd.
Hemostasis
Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
- Trial name
- NCT02014402
- Testing
- Human thrombin, Bovine thrombin
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Instituto Grifols, S.A.
Hemostasis of Arterial Punctures
Safety and Efficacy Study Comparing Thrombin for Arterial Sealing
This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI.
- Trial name
- NCT00388284
- Testing
- Arterial Sealing
- Where
- 6 sites in United States
- Volunteers
- 270 people
- Sponsor
- Vascular Solutions LLC
Peripheral Vascular Diseases, Hemostasis
Trial to Evaluate the Hemostatic Effect of Lyostypt® Versus Surgicel® in Arterial Bypass Anastomosis
The purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with Lyostypt® than with Surgicel®
- Trial name
- COBBANA (NCT00837954)
- Testing
- Lyostypt® AND Surgicel®, Lyostypt®, Surgicel®
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Aesculap AG
Hemostasis, Liver Surgery
Efficacy and Safety of Sangustop® as Haemostatic Agent Versus a Carrier-Bound Fibrin Sealant During Liver Resection
This is a multi-centre, patient-blinded, intra-operatively randomised controlled trial. A total of 126 patients planned for an elective liver resection will be enrolled in 9 surgical centres.
- Trial name
- ESSCALIVER (NCT00918619)
- Testing
- Sangustop, Tachosil
- Where
- 8 sites in Austria, Germany
- Volunteers
- 128 people
- Sponsor
- Aesculap AG
Hemostasis, Oral Contraceptive
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.
- Trial name
- NCT01252186
- Testing
- 91-day Levonorgestrel Oral Contraceptive, 28-day Levonorgestrel Oral Contraceptive, 28-day Desogestrel Oral Contraceptive
- Where
- 24 sites in United States, Italy
- Volunteers
- 265 people, healthy volunteers welcome
- Sponsor
- Teva Women's Health
Hemostasis
The Fibrin Patch Soft Tissue Study
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic…
- Trial name
- NCT00658723
- Testing
- Fibrin Pad, SURGICEL™
- Where
- 11 sites in United States
- Volunteers
- 141 people
- Sponsor
- Ethicon, Inc.
Heart Disease, Focus is on Testing Performance of CORA Hemostasis System.
Equivalency Study of the TEG and CORA Hemostasis Systems
This study is being performed to obtain data about the CORA system, a new device that is currently being tested and is not yet cleared for sale in the United State by the Food and Drug Administration (FDA).
- Trial name
- NCT01790386
- Where
- 4 sites in United States
- Volunteers
- 465 people, healthy volunteers welcome
- Sponsor
- Coramed Technologies LLC
Hemostasis, Surgical
The Safety and Effectiveness of PROCRIT (Epoetin Alfa) in Patients Undergoing Elective Major Abdominal and/or Pelvic Surgery
The primary purpose of the study is to compare the effect of perioperative (the time period describing the duration of a participants surgical procedure) administration of PROCRIT to that of Standard of Care (SOC) on the…
- Trial name
- NCT00350519
- Testing
- Epoetin alfa, Standard of Care
- Volunteers
- 37 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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