Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSaint Petersburg State University, Russia
About this trial
PRIORITY is a pragmatic, multi-center, cluster crossover trial that aims to evaluate whether implementing a policy of routine extended (intraoperative and 4 hour after transfer to ICU) use of fibrinolysis inhibitors leads to a decrease in post-operative blood transfusion compared to a policy that only involves intraoperative use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A hospital that performs a minimum of 250 open heart interventions per year.
Consent from hospital physicians regarding the prophylactic use of fibrinolysis inhibitors (more than 95% of physicians involved in the treatment of adult patients (>18 years) agree to adhere to the strategy of using fibrinolysis inhibitors as prescribed by the study protocol).
Disqualifiers
Hospital does not meet inclusion criteria
Trial design
Design model
Crossover
Treatments tested in this trial
No routine fibrinolysis inhibitors after surgery
Other interventionTranexamic acid or epsilon-aminocaproic acid should be administered intravenously during surgery. The dosage and method of administration should be followed according to the routine practice of the participating site.
Routine fibrinolysis inhibitors after surgery
Other interventionDuring surgery, it is recommended to administer 70% of the routine dose of Tranexamic acid or epsilon-aminocaproic acid intravenously. Following the surgery, the remaining 30% of this dose should be administered as a continuous intravenous infusion over the course of the first 4 hours.
Treatment groups
1,373 Participants
are divided into 2 treatment groupsGroup A: Intraoperative strategyActive comparator 1 intervention
Group B: Intraoperative and postoperative strategyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
RBC transfusion
The rate of red blood cells transfusion during the hospitalisation.
Time frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 monthsSecondary outcomes
1
Hospital stay
Duration of stay in the hospital, days
Time frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months2
Redo surgery requirement
Rate of reexplorations during the initial hospitalisation
Time frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months3
Haemoglobin on discharge
The last available blood haemoglobin level before the discharge
Time frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 months4
Total blood products requirement
Number blood products transfused, units
Time frame
From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov