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Completed

NCT Number: NCT02042898

Transfusion Requirements in Cardiac Surgery III

TRICS-III is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in high risk patients having cardiac surgery using a non-inferiority trial design.

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Key information

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 or older
  • Planned cardiac surgery using cardiopulmonary bypass
  • Informed consent obtained
  • Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Exclusion criteria

  • Patients who are unable to receive or who refuse blood products
  • Patients who are involved in a preoperative autologous pre-donation program
  • Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device
  • Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential.)
  • Patients who are unable to receive or who refuse blood products

Treatment and study plan

Restrictive Transfusion Strategy

Other

Liberal transfusion strategy

Other

Primary outcomes

  1. Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

    Composite score of any one of the following events occurring during the index hospitalization (from the start of surgery until hospital discharge or postoperative day 28, whichever comes first): (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit

Secondary outcomes

  1. Incidence of in-hospital all-cause mortality

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  2. Incidence of in-hospital myocardial infarction

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  3. Incidence of in-hospital new renal failure requiring dialysis

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  4. Incidence of in-hospital new focal neurological deficit

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  5. Length of stay in the ICU and hospital

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  6. Prolonged low output state defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump postoperatively or ventricular assist device

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  7. Duration of mechanical ventilation

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  8. Incidence of infection

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  9. Acute kidney injury (defined by Kidney Disease Improving Global Outcomes criteria)

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  10. Incidence of gut infarction

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  11. The proportion of patients transfused and the number of blood products and hemostatic products utilized (e.g. red cells, plasma, platelets, cryoprecipitate, factor VII) (index hospitalization)

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  12. Death

    Time frame: 6 months

  13. New onset dialysis (since incident surgery) status

    Time frame: 6 months

  14. Stroke

    Time frame: 6 months

  15. Coronary revascularization

    Time frame: 6 months

  16. Myocardial infarction

    Time frame: 6 months

  17. Health Care Utilization

    Time frame: 6 months

  18. Renal function, based on changes in postoperative serum creatinine

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  19. Incidence of Seizures

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  20. Incidence of Encephalopathy

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

  21. Incidence of Delirium

    Time frame: Up to hospital discharge or postoperative day 28 (whichever occurs first)

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Patients Undergoing Cardiac Surgery

Acronym: TRICS-III

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2014
Registry last updated
Aug 15, 2018

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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