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Completed

NCT Number: NCT01064167

Tranexamic Acid in Off-pump Coronary Surgery

The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.

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Key information

Conditions

Off Pump Coronary Artery Bypass Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital

Beijing, 100037, China

About this study

Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients for elective offpump coronary artery bypass surgery

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
  • Myocardial infarction < 7 days before surgery

Treatment and study plan

Tranexamic Acid

Drug

In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.

Primary outcomes

  1. Number of Patients Required Allogenic Red Blood Cells Transfusion

    Time frame: 1month postoperative

Secondary outcomes

  1. Postoperative Chest Tube Drainage

    Time frame: 24h postoperative

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting

Acronym: TAOPCAB

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 8, 2010
Registry last updated
Feb 3, 2011

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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