Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
NCT ID: NCT02640235
Last Updated: 2020-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2016-02-24
2017-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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CELSTAT
Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site
CELSTAT
Surgicel Original
Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site
Surgicel Original
Interventions
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CELSTAT
Surgicel Original
Eligibility Criteria
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Inclusion Criteria
1\. Subject is undergoing planned cardiothoracic, general or vascular surgery
Intraoperative
1\. Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
Exclusion Criteria
1. Subject needs emergency surgery
2. Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
3. Subject will undergo neurological or ophthalmological surgery
4. Subject will undergo urological or gynecological surgery
5. Subject has congenital coagulation disorder
6. Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
Intraoperative:
1. Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
2. Disseminated intravascular coagulopathy
18 Years
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Qing Li, MD
Role: STUDY_DIRECTOR
Baxter Healthcare Corporation
Locations
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Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida College of Medicine
Gainesville, Florida, United States
River City Clinical Research
Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Infectious Disease of Indiana, PSC
Carmel, Indiana, United States
University of Kentucky College of Medicine, Kentucky Clinic
Lexington, Kentucky, United States
Baystate Medical Center
Springfield, Massachusetts, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
MCVI at Covenant Medical Center
Saginaw, Michigan, United States
Truman Medical Center
Kansas City, Missouri, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Christ Hospital, Carl and Edyth Lindner Research Center
Cincinnati, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of North Texas Science Center
Fort Worth, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Texas Heart Institute, Baylor St. Luke's Medical Center
Houston, Texas, United States
Lake Washington Vascular
Bellevue, Washington, United States
Froedtert & The Medical College of Wisconsin Clinical Cancer Center
Milwaukee, Wisconsin, United States
University Hospital Kralovske Vinohrady, Clinic of Surgery
Prague, , Czechia
University Hosptial Kralovske Vinohrady, Clinic of Cardiac Surgery
Prague, , Czechia
DRK Clinics Berlin, Clinic of Surgery
Berlin, , Germany
Johann Wolfgang Goethe University Hospital, Clinic of General and Visceral Surgery
Frankfurt am Main, , Germany
Independent Public Teaching Hospital #2, Department of Vascular and General Surgery and Angiology
Szczecin, , Poland
Non-Public Specialist Healthcare Facility "MEDICUS"
Środa Wielkopolska, , Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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3584-001
Identifier Type: -
Identifier Source: org_study_id
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