Does tranexamic acid, a medicine used in treating and preventing bleeding problems, reduce the blood loss when it is injected directly into the knee joint after a total knee prosthesis

• Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]; The benefit of additional Tranexamic Acid (TXA) injected intra-articular at the end of surgery for patients undergoing a unilateral total knee arthroplasty in addition to conventional IV TXA to reduce the bleeding.; MedDRA version: 14.1Level: LLTClassification code 10003398Term: Arthroplasty of kneeSystem Organ Class: 100000004865

• Registration Number: EUCTR2013-003169-33-DK
• Lead Sponsor: Anders Troelsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-30
• Last Update Posted: 24 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

=18 years.

Undergoing surgery for unilateral total knee prothesis.

Give one's consent.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

•Allergic to TXA.
•In treatment with the following antikoagulantia: ADP receptorinhibitors, Vitamin K antagonist (within 5 to 7 days before the operation.). Faktor Xa inhibitors, trombine-inhibitors.
•Use og oral antikonceptiva
•Known with Trombofili.
•Reduced kidney function (S-kreatinine > 120 micromol/L)
•Participated in a clinical trial within the last 30 days.
•Alcoholisme and morphinism.
•Females: Menstruation within the last 12 months.
•Patients who are not able to speak and under stand Danish.
•Patients who refuse to receive blood products.
•Present acute thromboembolic event (DVT, AMI, lung embolia, cerebral infarction, pulmonary embolism)
•Disseminated intravascular coagulation (DIC) or active thromoembolic disease.
•Present active cancer disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified