Randomized clinical trial for Fibrin Sealant in knee surgery

Completed

• Conditions: total knee replacement; knee surgery; 10005944

• Registration Number: NL-OMON31572
• Lead Sponsor: Sanquin Bloedbank

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 257

Inclusion Criteria

•patients who will undergo knee replacement susrgery
•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
•Patients who need coumarine derivatives (acenocoumarol or fenprocoumon) < 3 days pre-operative or < 5 days post-operative

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>total volume of fluid in the drains at 6h post-operative.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: total volume of fluid in the drains at 24h post-operative,<br /><br>amount of blood transfused, size of the knee, amount of pain and mobility<br /><br>(quality of life) after surgery, length of stay in hospital, adverse events,<br /><br>satisfaction with fibrin sealant as used by the physician.</p><br>