PLATelet Function Operating Room Monitoring

Bleeding Clinical Trial

— PLATFORM  

Official title:

PLATelet Function Operating Room Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121898
• Other study ID #: PlateletMonitoring
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: June 2020
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 490
• Est. completion date: March 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Cardiac surgery with CPB

Exclusion Criteria:

• Known congenital coagulopathy

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage
• Platelet Dysfunction Due to Drugs

Intervention

Device:
• Platelet function test
Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Dyke C, Aronson S, Dietrich W, Hofmann A, Karkouti K, Levi M, Murphy GJ, Sellke FW, Shore-Lesserson L, von Heymann C, Ranucci M. Universal definition of perioperative bleeding in adult cardiac surgery. J Thorac Cardiovasc Surg. 2014 May;147(5):1458-1463.e1. doi: 10.1016/j.jtcvs.2013.10.070. Epub 2013 Dec 9. Review. — View Citation

Ranucci M, Baryshnikova E, Soro G, Ballotta A, De Benedetti D, Conti D; Surgical and Clinical Outcome Research (SCORE) Group. Multiple electrode whole-blood aggregometry and bleeding in cardiac surgery patients receiving thienopyridines. Ann Thorac Surg. 2011 Jan;91(1):123-9. doi: 10.1016/j.athoracsur.2010.09.022. — View Citation

Ranucci M, Colella D, Baryshnikova E, Di Dedda U; Surgical and Clinical Outcome Research (SCORE) Group. Effect of preoperative P2Y12 and thrombin platelet receptor inhibition on bleeding after cardiac surgery. Br J Anaesth. 2014 Dec;113(6):970-6. doi: 10.1093/bja/aeu315. Epub 2014 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative bleeding	Chest drain blood loss	12 hours
Secondary	Transfusions	RBC, FFP, and Platelet concentrate transfusions	24 hours