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NCT Number: NCT04754022

Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery

TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.

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Key information

Conditions

Disorder Cardiac Surgery Disease Heart Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 and ≤65 years of age
  • 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 refuse participation
  • 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)

Treatment and study plan

Restrictive Transfusion Strategy

Other

Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.

Liberal transfusion strategy

Other

Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.

Primary outcomes

  1. Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke).

    Time frame: Within 6 months after cardiac surgery.

    Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke).

Secondary outcomes

  1. Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Time frame: Within 6 months after cardiac surgery.

    Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

  2. Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).

  3. Length of stay in the ICU and hospital.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Length of stay in the ICU and hospital in days.

  4. Prolonged low output state.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively.

  5. Duration of mechanical ventilation.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Time on mechanical ventilation.

  6. Incidence of infection.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two out of three of the following criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement.

  7. Acute kidney injury.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline - a 50% increase in serum creatinine within 1 week or a 26.5 mmol/L increase within 48 hours.

  8. Delirium.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Confusion Assessment Method (CAM) or CAM-ICU (even on 1 occasion), or Intensive Care Delirium Screening Checklist (ICDSC) > 3, or 3D-CAM, or 4AT ≥4, or more than one dose of haloperidol or similar antipsychotic drug, or documented delirium by neurologist or neurosurgeon or psychiatrist consultation.

  9. Incidence of gut infarction.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Confirmed by imaging (e.g. angiography), autopsy, or through surgical means.

  10. Hospital visits.

    Time frame: Within 6 months after cardiac surgery.

    Hospitalization and/or emergency visits and coronary revascularization after index procedure.

  11. Transfusion requirements.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets).

  12. Incidence of seizures.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation.

  13. Incidence of encephalopathy.

    Time frame: Up to hospital discharge or after 28 days postoperatively, whichever comes first.

    Unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation.

Study contacts

Contact information is provided by the study sponsor or research team.

David Mazer, MD

CONTACT

[email protected]

416-864-5825

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 Younger Patients Undergoing Cardiac Surgery

Acronym: TRICS-IV

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Feb 15, 2021
Registry last updated
Nov 21, 2024

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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