Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy - Full Text View

Sponsor:	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
Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (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

Locations

Israel
Bnei-Zion MC
Haifa, Israel
Sheaba MC
Tel-Aviv, Israel
Rabin MC
Tel Aviv, Israel
Meir MC
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:	November 5, 2009
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

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on February 08, 2010