NCT Number: NCT06493227
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Cardiac surgery department, Saint-Petersburg state university hospital, Saint Petersburg, Russia
Routine use of fibrinolysis inhibitors is strongly recommended in cardiac surgery (recommendation level 1A). However, despite numerous studies on the pharmacodynamics and clinical effects of these drugs, there is still no consensus on the optimal dose and dosage regimen. As a result, there is wide variability in the use of fibrinolysis inhibitors across different clinics. Several studies have shown that peak activation of fibrinolysis occurs during cardiopulmonary bypass. However, elevated levels of markers of fibrinolytic activity in the blood plasma are observed for at least 2 hours after surgery and 4 hours after heparin neutralization. This suggests the potential for extended use of fibrinolysis inhibitors after surgery. There have been limited attempts to investigate the effectiveness of postoperative administration of fibrinolysis inhibitors, and these studies have been conducted on small samples or with retrospective designs. The authors of these studies were unable to identify the benefits of postoperative administration in terms of reducing bleeding risk and the need for blood transfusions. However, postoperative infusion of fibrinolysis inhibitors demonstrated a comparable safety profile. There is evidence suggesting that repeated administration of fibrinolysis inhibitors after cardiopulmonary bypass, rather than a single dose at the beginning of surgery, may be more beneficial. Due to uncertainty regarding the best approach (routine extended use of fibrinolysis inhibitors or no routine extended use of fibrinolysis inhibitors), we will compare the effects of a hospital policy that includes routine administration of fibrinolysis inhibitors 4 hours after surgery to a policy that avoids routine postoperative administration. The comparison will focus on the blood transfusion requirement during hospitalization among patients undergoing open heart surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tranexamic 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.
During 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.
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 months
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 months
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 months
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 months
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 months
Number blood products transfused, units
Contact information is provided by the study sponsor or research team.
Saint Petersburg State University, Russia
Other
The Practice of Routine Extended Perioperative Administration of Fibrinolysis Inhibitors to Reduce the Risk of Bleeding in Cardiac Surgery. Multicenter Prospective Randomized Cluster Crossover Study
Acronym: PRIORITY
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.
Published trials that share one or more normalized conditions with this study.
NCT02976415
Cardiac Disease, Cardiovascular Diseases
Hamilton, Ontario, Canada
View Trial DetailsNCT07228598
Antibiotic Resistance, Bacterial, Biofilms
Samsun, Turkey (Türkiye)
View Trial DetailsNCT07677540
Thoracic Surgery
Kfar Saba, Israel
View Trial DetailsNCT06893848
Abdominal Surgery Patients, Behavior
Neuchâtel, Switzerland
View Trial Details