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

Blood Loss Clinical Trial

Official title:

Evaluation of Intraarticular Tranexamic Acid to Reduction of Total Blood Loss Following Knee-Arthroplasty - A Randomized, Prospective, Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427412
• Other study ID #: H-3-2013-134
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2015
• Last updated: August 13, 2015
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Postoperative Blood Loss
• Postoperative Hemorrhage
• Thromboembolic Complications

Intervention

Drug:
• Tranexamic Acid
An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
• Saline water
30 ml of Saline water injected into the knee capsula at the end of surgery.
• Tranexamic Acid
An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total estimated blood loss		24 hours surgery	No
Secondary	Total estimated blood loss		2 days after surgery	No
Secondary	Thromboembolic complications	90 days followup for thromboembolic complications.	90 days postoperative	Yes
Secondary	Blood transfusion	Estimate the extent of blood transfusions during admission and readmission in relation to the knee replacement	while hospitalized expected 3 days.	No