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NCT Number: NCT01191554

Dose-ranging Study of Tranexamic Acid in Valve Surgery

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Valvular Heart Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital

Beijing, 100037, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)

Exclusion criteria

  • a history of bleeding disorders
  • active chronic hepatitis or cirrhosis
  • chronic renal insufficiency (serum creatinine > 2 mg/dl)
  • preoperative anemia (Hb < 10 g/dl)
  • previous cardiac surgery
  • urgent and emergency surgery

Treatment and study plan

Tranexamic Acid

Drug

High and low dosage. Loading dose followed by continuous infusion in operation.

Primary outcomes

  1. Frequency of allogeneic red blood cells transfused

    Time frame: 7 days post-operation

Secondary outcomes

  1. Chest tube drainage

    Time frame: 6 hours post-operation

  2. Chest tube drainage

    Time frame: 24 hours post-operation

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 31, 2010
Registry last updated
Nov 6, 2012

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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