Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding

Completed · Not applicable

Conditions studied: Bleeding Active

In brief

The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Key facts

Study ID

NCT02640235

Run by

Baxter Healthcare Corporation

People needed

260

Starts

2016-02-24

Expected to finish

2017-10-18

Last updated by the study team

2020-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preoperative
• Subject is undergoing planned cardiothoracic, general or vascular surgery
• Intraoperative
• 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.

You may not qualify if…

• Preoperative
• Subject needs emergency surgery
• Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
• Subject will undergo neurological or ophthalmological surgery
• Subject will undergo urological or gynecological surgery
• Subject has congenital coagulation disorder
• Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
• Intraoperative:
• Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
• Disseminated intravascular coagulopathy

Where it is running

• 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

Full record on ClinicalTrials.gov

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