Clinical Trial for Fibrin Sealant in Knee Surgery

This study has been withdrawn prior to enrollment.
(No agreement between investigator and sponsor)
Sponsor:
Collaborator:
MDM
Information provided by:
Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:
NCT00440921
First received: February 26, 2007
Last updated: October 19, 2009
Last verified: October 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Official Title: Randomized Clinical Trial for Fibrin Sealant in Knee Surgery

Resource links provided by NLM:


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

Estimated Enrollment: 578
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00440921     History of Changes
Other Study ID Numbers: RP06.008
Study First Received: February 26, 2007
Last Updated: October 19, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014