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Clinical Trials/NCT01637025
NCT01637025
Completed
Not Applicable

A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery

Baxter Healthcare Corporation23 sites in 4 countries111 target enrollmentMay 2012
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ConditionsIntra-operative Bleeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intra-operative Bleeding
Sponsor
Baxter Healthcare Corporation
Enrollment
111
Locations
23
Primary Endpoint
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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®)

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
November 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Occurrence of adverse events (AEs)/ adverse device effects (ADEs)

Time Frame: ≤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.

Study Sites (23)

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