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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014