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Completed

NCT Number: NCT02323373

Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.

The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.

Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible

Exclusion criteria

  • history or identified risk for deep vein thrombosis or pulmonary embolism
  • history of coagulation or cardiovascular disorders
  • vascular diseases
  • pregnancy
  • current use of anticoagulation drugs
  • previous orthopedic surgery in the legs.

Treatment and study plan

Tranexamic Acid - topical

Drug

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.

Other names: trans-4-(aminomethyl)cyclohexanecarboxylic acid

Placebo

Drug

100 ml of saline solution administered with anesthesia during 10 minutes

Other names: Saline solution

Tranexamic Acid - intravenous

Drug

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.

Other names: trans-4-(aminomethyl)cyclohexanecarboxylic acid

Primary outcomes

  1. Blood loss

    Time frame: up to 48 hours from the end of surgery, with drained volume registered every 6 hours.

    Volume of blood loss in the suction drain device after TKA surgery

Secondary outcomes

  1. Thrombosis

    Time frame: up to 15 days after surgery

    Patients with events of thrombosis after TKA

  2. Need for transfusion

    Time frame: during or after surgery, during hospital stay (hospital discharge took place in four days, in average)

    Number (or percentage) of patients requiring transfusion in TKA surgery

Sponsors and collaborators

Lead sponsor

Irmandade da Santa Casa de Misericordia de Sao Paulo

Other

Registry information

Official study title

Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: a Randomized Clinical Trial With 90 Patients

Acronym: TRANEXTKA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2014
Registry last updated
Jan 14, 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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