Clinical trials: Surgical Hemostasis
Benign Renal Tumors, Malignant Renal Tumors
First-in-Human Safety Study Of Laser Tissue Welding For Surtureless Laparoscopic Partial Nephrectomy
The objective of this pilot study will be to obtain a clinical safety and efficacy endpoint profile of laser tissue welding therapy for sealing the resected kidney surface after laparoscopic partial nephrectomy required for…
- Trial name
- LTW-KIDNEY (NCT02061605)
- Testing
- Laser Tissue Welding Device
- Where
- United States
- Sponsor
- Laser Tissue Welding, Inc.
Hemorrhage
Study to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique
This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.
- Trial name
- NCT03957356
- Testing
- HLBLS-200
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- HLB Cell Co., Ltd.
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
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
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
Surgical Bleeding
Safety and Efficacy of WoundClot Surgical
The goal of this clinical trial is to verify that WoundClot Surgical helps stop bleedings which may occur during surgery. It will also help learn more about the safety of WoundClot Surgical.
- Trial name
- WCS-1 (NCT06696092)
- Testing
- Hemostatic Agent
- Where
- 8 sites in Romania
- Volunteers
- 72 people
- Sponsor
- Core Scientific Creations Ltd.
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.
Hemostasis,Surgical
Hemostatic Closure of Femoral Artery Access Site, Using the QuickClose
The QuickClose study is a prospective, non-randomized study, to evaluate the safety and efficacy of the QuickClose device using two different dose types of heat exposure.
- Trial name
- NCT00507013
- Testing
- QuickClose device
- Where
- Israel
- Volunteers
- 8 people
- Sponsor
- CardioDex
Surgical Bleeding
Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery
The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows.
- Trial name
- NCT04734535
- Testing
- HEMOBLAST™ Bellows, absorbable gelatin sponge with thrombin
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Dilon Technologies Inc.
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
Surgical Bleeding
Topical Raplixa for Surgical Bleeding in Children
The purpose of the study is to determine if Raplixa plus Gelfoam is better than Gelfoam alone in stopping mild to moderate bleeding in children having surgery.
- Trial name
- NCT02117349
- Testing
- Raplixa, Gelfoam, Rescue treatment
- Where
- 13 sites in United States
- Volunteers
- 55 people
- Sponsor
- Mallinckrodt
Blood Loss, Surgical
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.
- Trial name
- CLOT (NCT02359994)
- Testing
- PerClot Polysaccharide Hemostatic System, Arista AH
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Artivion Inc.
Peripheral Vascular Disease
Evaluation of Fibrin Sealant 2 in Vascular Surgical Procedures
A comparison of a fibrin sealant versus manual compression in stopping surgical bleeding during vascular procedures.
- Trial name
- NCT00154141
- Testing
- Fibrin sealant (FS2)
- Where
- 17 sites in United States, United Kingdom
- Volunteers
- 150 people
- Sponsor
- Ethicon, Inc.
Bleeding, Surgical Wound
Traumacel FAM Trium in the Post-market Surveillance Phase
The investigational medical device Traumacel FAM Trium is a sterile plant polysaccharide haemostatic agent based on the oxidized cellulose in the form of multilayer nonwoven fabric.
- Trial name
- NCT05177874
- Testing
- Traumacel FAM Trium, Surgicel Fibrillar
- Where
- Czechia
- Volunteers
- 98 people
- Sponsor
- Bioster, a.s.
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Surgery
The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.
- Trial name
- NCT00245336
- Testing
- rThrombin, bovine thrombin
- Where
- 29 sites in United States
- Volunteers
- 401 people
- Sponsor
- ZymoGenetics
Hemophilia A
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion…
- Trial name
- NCT00243659
- Testing
- ReFacto AF
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 30 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Blood Loss, Surgical, Hemostasis
OSHES - Observational Study on Hemostasis in Surgery (TC-022-IT)
OSHES (= Observational Study on Hemostasis in Surgery) is a non interventional register settled in Italy with the purpose of collecting data on 800 patients intra-operatively treated with hemostatic supporting agents/techniques…
- Trial name
- NCT00279383
- Testing
- Fibrinogen (human) + thrombin (human) (TachoSil)
- Where
- Denmark
- Volunteers
- 800 people
- Sponsor
- Nycomed
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.
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Vascular Surgical Bleeding
Safety and Efficacy Study of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Peripheral Vascular Surgery
The purpose of this study is to demonstrate that the application of Fibrin Sealant Grifols provides a measurable benefit when compared to hemostasis achieved through conventional surgical technique (suture) and by standard…
- Trial name
- NCT01662856
- Testing
- Fibrin Sealant Grifols, Manual Compression
- Where
- 38 sites in United States, Hungary and 2 more
- Volunteers
- 225 people
- Sponsor
- Instituto Grifols, S.A.