Oxidized Cellulose hEmostAsis evaluatioN

Not Applicable

Completed

• Conditions: Intra-operative Bleeding

• Registration Number: NCT01637025
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)	≤30 ± 5 days/ end-of-study visit after device application	Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.

Trial Locations

Locations (23)

Chirurgicke oddeleni Nemocnice Liberec; 🇨🇿 Liberec, Czech Republic

Kardiochirurgicke oddeleni FN Plzen; 🇨🇿 Plzen - Lochotin, Czech Republic

Chirurgicka klinika FN KV; 🇨🇿 Praha, Czech Republic

Chirurgicka klinika UVN; 🇨🇿 Praha, Czech Republic

Chirurgicke oddeleni Fakultni nemocnice Na Bulovce; 🇨🇿 Praha, Czech Republic

Kardiochirurgicka klinika FN KV; 🇨🇿 Praha, Czech Republic

Klinika kardiovaskularni chirurgie IKEM; 🇨🇿 Praha, Czech Republic

Klinik für Allgemein-, Visceral- und Transplantationschirurgie Charité Berlin; 🇩🇪 Berlin, Germany

Klinik für Allgemein-, Visceral-, Gefäß- und Thoraxchirurguie Charité Universitätsmedizin Berlin - Campus Mitte; 🇩🇪 Berlin, Germany

Allgemein- und Viszeralchirurgie Johann Wolfgang Goethe Universitätsklinikum; 🇩🇪 Frankfurt am Main, Germany

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