Analysis of Blood Loss With the Use of Fibrin Sealant in Total Knee Replacement Surgery – A Randomised Controlled Study - RCT evaluating effects of fibrin sealant on blood loss in TKR ver 001

Conditions: Blood loss in total knee arthroplasty

Registration Number: EUCTR2009-011492-73-GB

Lead Sponsor: Swindon and Marlborough NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria:

1. Subjects must be willing to participate in the study, and provide written informed consent.
2. Subjects scheduled to undergo primary, unilateral, cemented total knee replacement for a diagnosis of primary osteoarthritis.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria

1. Subjects who have had previous surgery to the knee (with exception of arthroscopic procedures);
2. Subjects with a recognised bleeding diasthesis;
3. Subjects with platelet or bone-marrow disorders;
4. Subjects undergoing or potentially requiring warfarin or other anticoagulation therapy (including those with a history of thrombotic or thromboembolic events in whom additional post-operative thromboprophylaxis would be required);
5. Subjects undergoing uncemented knee replacements;
6. Subjects undergoing bilateral total knee replacement surgery.
7. Subjects with recognised immunocompromise, and those with a history of severe or anaphylactic reaction to human blood products.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does the use of a fibrin sealant in addition to existing methods to control bleeding reduce postoperative blood loss?;Secondary Objective: Should blood loss be lessened:<br> Does this reduce the need for blood transfusion?<br> Is a more rapid return to function obtained?<br> Is post-operative swelling less?<br> Is pain reduced?<br> Is length of hospital stay decreased?<br>Are there any complications associated with the use of fibrin sealant?;Primary end point(s): Calculated total blood loss in each group

Secondary Outcome Measures