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Clinical Trial for Fibrin Sealant in Knee Surgery

This study has been withdrawn prior to enrollment.
(No agreement between investigator and sponsor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00440921
First Posted: February 27, 2007
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MDM
Information provided by:
Sanquin Research & Blood Bank Divisions
  Purpose
  • Thermogenesis is a company that sells a machine for the production of fibrin sealant of single donor plasma, the CryoSeal Fibrin Sealant System (CS-1).
  • Fibrin sealant consists of two components: cryoprecipitate and thrombin. Cryoprecipitate is the fraction of human plasma that contains concentrated coagulation factors, such as fibrinogen. Thrombin is an enzyme that facilitates the conversion of fibrinogen into fibrin, so that a clot will be formed.
  • Fibrin sealant can be used in surgery to increase hemostasis in the wound after e.g. knee- or hip replacement, cosmetical surgery or partial liverresections.
  • Until now, mainly autologous plasma was used to produce fibrin sealant with the CS-1. Within Sanquin there is a question whether fibrin sealant can be produced from the allogeneic quarantaine plasma that is in stock. Therefore in this study will be studied whether allogenous single donor fibrin sealant produced using the CS-1 is effective in wound healing and as consequence of this can be registered as a product of Sanquin. To answer these questions a national working party is formed, working party Fibrin Sealant.
  • So far, three man personnel in Sanquin Blood Bank Nort East Region (SBNO) are certified by Thermogenesis to use the CS-1 for production of fibrin sealant and an in vitro validation has been performed.
  • The next step will be a study for the in vivo effectiveness of fibrin sealant produced of single donor allogeneic quarantaine plasma using the CS-1. As control patients without fibrin sealant treatment will be studied. Two hospitals (Refaja Hospital in Stadskanaal and Wilhelmina hospital in Assen) are already interested in participating in this study. Probably, three more hospitals will participate.
  • The use of fibrin sealant will be studied in a prospective randomized trial for patients undergoing knee and hip replacements.

Condition Intervention
Total Knee-replacement Total Hip-replacement Drug: Single donor Allogenous Fibrin Sealant

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial for Fibrin Sealant in Knee Surgery

Further study details as provided by Sanquin Research & Blood Bank Divisions:

Primary Outcome Measures:
  • wound healing

Secondary Outcome Measures:
  • total blood loss until 24h post-operative
  • amount of blood transfused
  • motion of the joint (knee) after surgery
  • amount of pain after surgery
  • use of antibiotics
  • wound infections
  • stay in hospital
  • adverse events
  • satisfaction with fibrin sealant as used by the physician

Enrollment: 0
Study Start Date: December 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age, minimum of 18 years
  • Gender, man or woman
  • Admission of the patient after informed consent

Exclusion Criteria:

  • Liver failure
  • Congenital or acquired coagulation disorders
  • Thrombocytopenia, < 100 x10^9 PLT/L
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00440921


Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
MDM
Investigators
Study Chair: Coen van Delden, PhD Sanquin Blood Bank North East Region
  More Information

ClinicalTrials.gov Identifier: NCT00440921     History of Changes
Other Study ID Numbers: RP06.008
First Submitted: February 26, 2007
First Posted: February 27, 2007
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Sanquin Research & Blood Bank Divisions:
fibrin sealnat
knee replacement
hip replacement
woud healing
blood loss
clinical trial
randomized

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants