Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Phase 2

Completed

• Conditions: Hemostatic Techniques; Nephrectomy

• Registration Number: NCT00598130
• Lead Sponsor: OMRIX Biopharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-23
• Study First Submitted QC: 2008-01-17
• Study First Posted: 2008-01-18
• Study Start: 2008-02
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-05
• Last Update Posted: 2009-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of successes at 10 minutes following randomization	10 minutes

Secondary Outcome Measures

Name	Time	Method
Proportion of successes at 5 minutes following randomization	5 minutes

Trial Locations

Locations (4)

Bnei-Zion MC; 🇮🇱 Haifa, Israel

Meir MC; 🇮🇱 Kfar Saba, Israel

Rabin MC; 🇮🇱 Tel Aviv, Israel

Sheaba MC; 🇮🇱 Tel-Aviv, Israel