Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty

Phase 4

Completed

• Conditions: Postoperative Blood Loss; Thromboembolic Complications; Blood Loss
• Interventions: Drug: Saline water; Drug: Tranexamic Acid

• Registration Number: NCT02427412
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

A randomized, prospective, placebo-controlled study which aims to evaluate the effect of combined intraarticular and intravenous Tranexamic acid on total blood loss following unilateral knee replacement versus only intravenous tranexamic acid.

Detailed Description

Intravenous (IV) Tranexamic acid is already well-established and well-documented regarding significant effect on reducing blood loss following knee replacement. A few studies more shown a similar effect of intraarticular (IA) injected Tranexamic acid into the knee joint at the end of surgery for knee replacement.

In this study investigators therefore investigate the possible combined effect of added intraarticular tranexamic acid to conventional intravenous Tranexamic acid.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-04-28
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• > 18 years old
• Unilateral knee replacement
• Must be able to give oral and written consent

Exclusion Criteria

• General Anesthetized
• Allergic to Tranexamic acid
• In treatment with the following anticoagulants: Adenosine diphosphate receptor inhibitors or vitamin K antagonist within in the last 5 days. Factor Xa inhibitor and thrombin inhibitor.
• Use of oral anticonceptive.
• Reduced kidney function (S-creatinine > 120 micromol/L)
• Medicine or alcohol abuse
• Females with menstruation within the last 12 mounts.
• Any kind of cancer disease
• Rheumatoid arthritis
• Have participated in a clinical trial within the last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IA Saline Water + IV tranexamic Acid	Saline water	30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
IA Tranexamic acid + IV Tranexamic Acid	Tranexamic Acid	3 gram of Tranexamic acid diluted into 30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.
IA Saline Water + IV tranexamic Acid	Tranexamic Acid	30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.

Primary Outcome Measures

Name	Time	Method
Total estimated blood loss	24 hours surgery

Secondary Outcome Measures

Name	Time	Method
Thromboembolic complications	90 days postoperative	90 days followup for thromboembolic complications.
Total estimated blood loss	2 days after surgery
Blood transfusion	while hospitalized expected 3 days.	Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark