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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Total estimated blood loss
    • Time Frame: 24 hours surgery

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hvidovre University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Christian Skovgaard Nielsen, MD – Hvidovre University Hospital
  • Overall Official(s)
    • Henrik Husted, PhD, Study Director, Hvidovre University Hospital

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