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Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

This study has been completed.
Sponsor:
Information provided by:
OMRIX Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00598130
First received: December 23, 2007
Last updated: November 5, 2009
Last verified: November 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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
Experimental: I
patients who will be treated in accordance with standard of care
 Biological: Fleece
Fibrin Patch
Active Comparator: II
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
Meir MC
Kfar Saba, Israel
Rabin MC
Tel Aviv, Israel
Sheaba MC
Tel-Aviv, Israel
Sponsors and Collaborators
OMRIX Biopharmaceuticals
Investigators
Principal Investigator: Yoram Dekel, MD Rabin MC
  More Information

No publications provided by OMRIX Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eran Kurman - Clinical Affaires Manager, Omrix Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00598130     History of Changes
Other Study ID Numbers: FL-PN-002-IS, MoH
Study First Received: December 23, 2007
Last Updated: November 5, 2009
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:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013