Platelets Antiaggregation Control Enhancement (PACE) Study

NCT ID: NCT01218074

Last Updated: 2018-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2017-09-30

Brief Summary

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Many patients undergo cardiac surgery without proper suspension of antiaggregation drugs. This is blamed to increase dramatically bleeding and use of allogenic blood transfusions. The investigators test the hypothesis that routine use of aggregometry could show antiaggregated patient and lead to normalization of platelet function via administration of Desmopressin thus limiting bleeding and transfusions.

Detailed Description

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Conditions

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Bleeding Blood Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Thromboelastography alone

Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.

Group Type ACTIVE_COMPARATOR

Thromboelastography Alone

Intervention Type DEVICE

Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.

Aggregometry+Tromboelastography

Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.

Group Type EXPERIMENTAL

Aggregometry+Thromboelastography

Intervention Type DEVICE

Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.

Interventions

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Aggregometry+Thromboelastography

Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.

Intervention Type DEVICE

Thromboelastography Alone

Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* all patients undergoing surgical myocardial revascularization.

Exclusion Criteria

* none.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Luca Weltert

Project Leader Luca Weltert

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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European Hospital

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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00-04

Identifier Type: -

Identifier Source: org_study_id

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