Clinical Trial for Fibrin Sealant in Knee- and Hip Surgery - Full Text View

Sponsored by:	Sanquin Research & Blood Bank Divisions
Information provided by:	Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier:	NCT00440921

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

MedlinePlus related topics: Knee Replacement

Drug Information available for: Fibrin Beriplast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Clinical Trial for Fibrin Sealant in Knee- and Hip 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

Estimated Enrollment:	578
Study Start Date:	June 2007
Estimated Study Completion Date:	January 2008

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440921

Contacts

Contact: Coen van Delden, PhD		c.vandelden@sanquin.nl
Contact: Janny de Wildt-Eggen, PhD		j.dewildt@sanquin.nl

Sponsors and Collaborators

Sanquin Research & Blood Bank Divisions

Investigators

Study Chair:

Coen van Delden, PhD

Sanquin Blood Bank North East Region

More Information

Study ID Numbers:	RP06.008
Study First Received:	February 26, 2007
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00440921
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

Study placed in the following topic categories:

Fibrin Tissue Adhesive
Hemorrhage

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 14, 2009