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Clinical Trials/NCT00598130
NCT00598130
Completed
Phase 2

A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

OMRIX Biopharmaceuticals4 sites in 1 country30 target enrollmentFebruary 2008
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ConditionsHemostatic TechniquesNephrectomy

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Hemostatic Techniques
Sponsor
OMRIX Biopharmaceuticals
Enrollment
30
Locations
4
Primary Endpoint
Proportion of successes at 10 minutes following randomization
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
February 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients undergoing elective open partial nephrectomy
  • •Patients must be willing to participate in the study, and provide written informed consent

Exclusion Criteria

  • •Patients with a tumor diameter greater than 4 cm
  • •Any additional surgical intervention other than partial nephrectomy
  • •Patients with only one functional kidney
  • •Patients with known intolerance to blood products or other components of the product

Outcomes

Primary Outcomes

Proportion of successes at 10 minutes following randomization

Time Frame: 10 minutes

Secondary Outcomes

  • Proportion of successes at 5 minutes following randomization(5 minutes)

Study Sites (4)

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