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

Hvidovre University Hospital

Status and phase

Completed

Phase 4

Conditions

Thromboembolic Complications

Postoperative Blood Loss

Blood Loss

Treatments

Drug: Saline water

Drug: Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02427412

H-3-2013-134

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

IA Tranexamic acid + IV Tranexamic Acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid

IA Saline Water + IV tranexamic Acid

Placebo Comparator group

Description:

30 ml Saline Water injected into the knee capsula after ended surgery + 1 g of Tranexamic acid injected intravenous at the start of surgery.

Treatment:

Drug: Tranexamic Acid

Drug: Saline water