PLATelet Function Operating Room Monitoring | NCT03121898

Studies
PLATelet Function Operating Room Monitoring

NCT03121898

Sponsor

IRCCS Policlinico S. Donato

Status

Completed

Last Update Posted

Jun 22, 2020Actual

Enrollment

490Actual

Phase

Not provided

Conditions

Platelet Dysfunction Due to Drugs
Bleeding

Interventions

Platelet function test

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2017Actual

Primary Completion Date

Jan 31, 2018Actual

Completion Date

Mar 31, 2018Actual

First Submitted Date

Apr 17, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2020

Last Update Posted Date

Jun 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marco Ranucci, Head of Cardiothoracic Anesthesia and ICU depy, IRCCS Policlinico S. DonatoPrincipal Investigator

Lead Sponsor

IRCCS Policlinico S. DonatoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

490Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet function test	Device	Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative bleeding	Chest drain blood loss	12 hours

Secondary Outcomes

Measure	Description	Time Frame
Transfusions	RBC, FFP, and Platelet concentrate transfusions	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiac surgery with CPB

Exclusion Criteria:

Known congenital coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Adult cardiac surgery patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marco Ranucci, MD	IRCCS Policlinico S. Donato	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Policlinico San Donato		San Donato Milanese	Milan	20097	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21172499	Background	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.
25209096	Background

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006403	Hematologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis