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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Hvidovre University Hospital

Current Primary Outcome: Total estimated blood loss [ Time Frame: 24 hours surgery ]

Original Primary Outcome:

  • Total estimated blood loss [ Time Frame: 24 hours surgery ]
  • Total estimated blood loss [ Time Frame: 2 days after surgery ]


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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


Information By: Hvidovre University Hospital

Dates:
Date Received: April 20, 2015
Date Started: January 2014
Date Completion:
Last Updated: August 13, 2015
Last Verified: May 2015