PLATelet Function Operating Room Monitoring
PLATFORM
1 other identifier
observational
490
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedJune 22, 2020
June 1, 2020
12 months
April 17, 2017
June 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative bleeding
Chest drain blood loss
12 hours
Secondary Outcomes (1)
Transfusions
24 hours
Interventions
Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest
Eligibility Criteria
Adult cardiac surgery patients
You may qualify if:
- Cardiac surgery with CPB
You may not qualify if:
- Known congenital coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097, Italy
Related Publications (3)
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.
PMID: 21172499BACKGROUNDRanucci 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.
PMID: 25209096BACKGROUNDDyke 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.
PMID: 24332097BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Ranucci, MD
IRCCS Policlinico S. Donato
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Cardiothoracic Anesthesia and ICU depy
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 20, 2017
Study Start
February 1, 2017
Primary Completion
January 31, 2018
Study Completion
March 31, 2018
Last Updated
June 22, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share