Blood transfusion needs in younger patients undergoing cardiac surgery. An international, multicenter, randomized, controlled study to clarify transfusion thresholds in cardiac surgical patients.
Zusammenfassung der Studie
Every heart operation is associated with blood loss during and after the procedure. Depending on the blood value before the operation as well as the amount of blood loss during the procedure, this can lead to anemia, which may need to be treated with a transfusion of foreign blood. Anemia as well as a transfusion are associated with side effects and risks. Therefore, before any transfusion, the potential benefits and risks must be weighed against each other. The patients included in the study are divided into 2 groups. Group 1: liberal strategy, meaning that a transfusion during the operation and in the intensive care unit occurs with a hemoglobin level below 95 g/l and in the normal ward with a hemoglobin level below 85 g/l. Group 2: restrictive strategy, meaning a transfusion during the operation, in the intensive care unit, and in the normal ward occurs with a hemoglobin level below 75 g/l. If symptoms are present that may be associated with a low hemoglobin level, the treating physician is not bound by the group assignment and can administer a blood transfusion at any time if deemed necessary. In both groups, the reference value for a blood transfusion is within the range of current valid international guidelines, meaning at a hemoglobin level between 75 g/l and 95 g/l. A similar study, TRICS III, has already been conducted at our site. The results show that a low threshold of red blood cells for the administration of blood products is not detrimental. (New England Journal of Medicine) This is particularly true for older patients (over 65 years). Therefore, a cautious transfusion of blood products is recommended for older patients. The aim of this follow-up study is to determine the optimal blood transfusion threshold for correcting anemia during and after cardiac surgery in patients aged 18 to 65 years.
(BASEC)
Untersuchte Intervention
The patients included in the study are divided into 2 groups.
Group 1 follows a liberal strategy, meaning that a transfusion during the operation and in the intensive care unit occurs with a hemoglobin level below 95 g/l and in the normal ward with a hemoglobin level below 85 g/l.
Group 2 follows a restrictive strategy, meaning a transfusion during the operation, in the intensive care unit, and in the normal ward occurs with a hemoglobin level below 75 g/l.
In both groups, the blood transfusion value is within the range of current valid international guidelines, meaning at a hemoglobin level between 75 g/l and 95 g/l.
(BASEC)
Untersuchte Krankheit(en)
The study aims to clarify at what level of red blood cells (hemoglobin) in younger (<65 years) patients undergoing cardiac surgery a blood transfusion is necessary.
(BASEC)
Age: 18-65 years planned cardiac surgical operation on cardiopulmonary machine present, signed informed consent risk assessment in cardiac surgery (www.euroscore.org/calcold.html) (BASEC)
Ausschlusskriterien
no present informed consent patients who cannot or do not wish to receive blood products patients participating in a preoperative autologous blood donation patients undergoing heart transplantation or a surgical procedure for the implantation of a ventricular assist device pregnant and breastfeeding women (BASEC)
Studienstandort
Basel, Bern
(BASEC)
Sponsor
Dr. David Mazer, St. Michael’s Hospital (Toronto, ON, Canada) Prof. Daniel Bolliger, Universitätsspital Basel, Schweiz
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. Daniel Bolliger
+41 61 328 64 23
daniel.bolliger@clutterusb.chAnästhesiologie Spitalstrasse 21 4031 Basel
(BASEC)
Allgemeine Auskünfte
Unity Health Toronto,MOUNT SINAI HOSPITAL,
416-864-5825
David.Mazer@unityhealth.to(ICTRP)
Wissenschaftliche Auskünfte
Unity Health Toronto,MOUNT SINAI HOSPITAL,
416-864-5825
David.Mazer@unityhealth.to(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.06.2022
(BASEC)
ICTRP Studien-ID
NCT04754022 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
TRICS IV: Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery (BASEC)
Wissenschaftlicher Titel
An International, Multi-centre, Randomized Controlled Trial to Assess Transfusion Thresholds in Younger Patients Undergoing Cardiac Surgery (ICTRP)
Öffentlicher Titel
Transfusion Requirements in Younger Patients Undergoing Cardiac Surgery (ICTRP)
Untersuchte Krankheit(en)
Disorder;Heart;Postoperative;Cardiac Surgery (ICTRP)
Untersuchte Intervention
Other: Restrictive Transfusion Strategy;Other: Liberal transfusion strategy (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years
Inclusion Criteria:
1. =18 and =65 years of age
2. Planned cardiac surgery using cardiopulmonary bypass
3. Informed consent obtained
4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of
6 or more
Exclusion Criteria:
1. Patients who refuse participation
2. Patients who are unable to receive or who refuse blood products
3. Patients who are involved in a preoperative autologous pre-donation program
4. Patients who are having a heart transplant or having surgery solely for an insertion
of a ventricular assist device
5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to
randomization for women of childbearing potential) (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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). (ICTRP)
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).;Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke).;Length of stay in the ICU and hospital.;Prolonged low output state.;Duration of mechanical ventilation.;Incidence of infection.;Acute kidney injury.;Delirium.;Incidence of gut infarction.;Hospital visits.;Transfusion requirements.;Incidence of seizures.;Incidence of encephalopathy. (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
David Mazer, MD;Nadine Shehata, MD;David Mazer, MD, David.Mazer@unityhealth.to, 416-864-5825, Unity Health Toronto,MOUNT SINAI HOSPITAL, (ICTRP)
Sekundäre IDs
TRICS-IV (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04754022 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar