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NCT Number: NCT02427412

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

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.

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Key information

Conditions

Blood Loss Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Blood Loss Postoperative Complications Postoperative Hemorrhage Thromboembolic Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Hvidovre, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

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

Saline water

Drug

30 ml of Saline water injected into the knee capsula at the end of surgery.

Other names: NaCl water

Primary outcomes

  1. Total estimated blood loss

    Time frame: 24 hours surgery

Secondary outcomes

  1. Total estimated blood loss

    Time frame: 2 days after surgery

  2. Thromboembolic complications

    Time frame: 90 days postoperative

    90 days followup for thromboembolic complications.

  3. 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

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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