Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

This study is currently recruiting participants.

Verified by OMRIX Biopharmaceuticals, August 2008

First Received: December 23, 2007 Last Updated: August 19, 2008 History of Changes

Sponsored by:	OMRIX Biopharmaceuticals
Information provided by:	OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00598130

Purpose

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.

Condition	Intervention	Phase
Hemostatic Techniques Nephrectomy	Biological: Fleece	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Fibrin

U.S. FDA Resources

Further study details as provided by OMRIX Biopharmaceuticals:

Primary Outcome Measures:

Proportion of successes at 10 minutes following randomization [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of successes at 5 minutes following randomization [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental patients who will be treated in accordance with standard of care	Biological: Fleece Fibrin Patch
II: Active Comparator patients for which the Fibrin Fleece will be applied directly on the active bleeding site.	Biological: Fleece Fibrin Patch

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598130

Contacts

Contact: Eran Kurman

+972 544984858

eran@omrix.co.il

Locations

Israel
Bnei-Zion MC	Recruiting
Haifa, Israel
Sheaba MC	Not yet recruiting
Tel-Aviv, Israel
Rabin MC	Active, not recruiting
Tel Aviv, Israel
Meir MC	Not yet recruiting
Kfar Saba, Israel

Sponsors and Collaborators

OMRIX Biopharmaceuticals

Investigators

Principal Investigator:

Yoram Dekel, MD

Rabin MC

More Information

No publications provided

Responsible Party:	Omrix Biopharmaceuticals ( Eran Kurman - Clinical Affaires Manager )
Study ID Numbers:	FL-PN-002-IS, MoH
Study First Received:	December 23, 2007
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00598130 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by OMRIX Biopharmaceuticals:

Patients undergoing elective open partial nephrectomy surgery
Excision of a kidney

Study placed in the following topic categories:

Hemostatics

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on September 03, 2009