Clinical Trial for Fibrin Sealant in Knee Surgery

NCT00440921 | Withdrawn DMC

• 1 other identifier: RP06.008
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

• 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.

Conditions

Total Knee-replacement; Total Hip-replacement

Keywords

fibrin sealnat; knee replacement; hip replacement; woud healing; blood loss; clinical trial; randomized

Outcome Measures

Primary Outcomes (1)

• wound healing

Secondary Outcomes (9)

• 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

Interventions

Single donor Allogenous Fibrin Sealant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Liver failure
• Congenital or acquired coagulation disorders
• Thrombocytopenia, \< 100 x10\^9 PLT/L

Sponsors & Collaborators

• Sanquin Research & Blood Bank Divisions: lead
• MDM: collaborator

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Coen van Delden, PhD

  Sanquin Blood Bank North East Region

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2007
• First Posted: February 27, 2007
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 2, 2015

Record last verified: 2015-06