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

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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss; Postoperative Blood Loss; Thromboembolic Complications
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Tranexamic Acid; Drug: Saline water

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Hvidovre University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IA Tranexamic acid + IV 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.	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.; Other Names: Cyclokapron; Drug: Tranexamic Acid; An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.; Other Names: Cyklocapron
Placebo Comparator: IA Saline Water + IV 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.	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.; Other Names: Cyclokapron; Drug: Tranexamic Acid; An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.; Other Names: Cyklocapron; Drug: Saline water; 30 ml of Saline water injected into the knee capsula at the end of surgery.; Other Names: NaCl water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total estimated blood loss	24 hours surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hvidovre University Hospital
• Investigators: Study Director: Henrik Husted, PhD, Hvidovre University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: April 20, 2015
• First Submitted That Met QC Criteria: April 27, 2015
• First Posted (Estimate): April 28, 2015

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: August 13, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Tranexamic Acid; Blood loss; Blood transfusion; Thrombolic complication; Total blood loss 24 h after ended surgery.; Total blood loss 2 days after ended surgery.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Exsanguination; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: H-3-2013-134