PLATelet Function Operating Room Monitoring

Completed

• Conditions: Bleeding; Platelet Dysfunction Due to Drugs

• Registration Number: NCT03121898
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief Summary

Prospective cohort study on adult cardiac surgery patients. Platelet function evaluated before and after cardiopulmonary bypass. Bleeding and transfusion recorded. Primary endpoint is finding the association between postoperative platelet function and bleeding.

Detailed Description

Preoperative platelet function is a known determinant of postoperative bleeding in cardiac surgery patients (1,2). Conversely, there is a lack of information with respect to postoperative platelet function and postoperative bleeding, and specific cut-off values have not been identified yet.

This study will verify the hypothesis that postoperative platelet function is associated with bleeding, and will test the ability of platelet function tests (PFTs) in predicting severe postoperative bleeding. Additional analyses linking platelet function to other preoperative and intraoperative conditions are planned.

Patients: Enrollment between February 2017 and January 2018. 800 consecutive adult cardiac surgery patients are considered based on our usual surgical activity. Exclusion criteria: unwillingness to participate, known congenital coagulopathy. Moderate/severe bleeding occurs in about 12% of our patient population. Considering a 15% dropout rate, there are about 80 predicted events. Power analysis: to build a predictive model, at least 60 events of moderate/severe bleeding are required. The study will be stopped at reaching (whatever comes first) 800 enrolled pts; 60 events; or 31st January 2018.

Methods: all the patients will receive a preoperative (in the operating room) PFT (ADPtest and TRAPtest) using the aggregometry Multiplate (Roche). The same test will be repeated after protamine administration at the end of CPB.

Definitions of bleeding: 12-hours chest drain blood loss; moderate/severe bleeding adjudicated based on the universal definition of perioperative bleeding (3).

Statistics: ROC analysis with identification of adequate cut-off values and definition of the PPV and NPV

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2018-01-31
• Study Completion: 2018-03-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

• Cardiac surgery with CPB

Exclusion Criteria

• Known congenital coagulopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative bleeding	12 hours	Chest drain blood loss

Secondary Outcome Measures

Name	Time	Method
Transfusions	24 hours	RBC, FFP, and Platelet concentrate transfusions

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy