Platelets Antiaggregation Control Enhancement (PACE) Study

Not Applicable

Terminated

• Conditions: Bleeding; Blood Transfusion
• Interventions: Device: Aggregometry+Thromboelastography; Device: Thromboelastography Alone

• Registration Number: NCT01218074
• Lead Sponsor: Cardiochirurgia E.H.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-11
• Study Start: 2010-12
• Primary Completion: 2016-09
• Study Completion: 2017-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• all patients undergoing surgical myocardial revascularization.

Exclusion Criteria

• none.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aggregometry+Tromboelastography	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.
Thromboelastography alone	Thromboelastography Alone	Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.

Primary Outcome Measures

Name	Time	Method
Bleeding Volume	12 hours after end of operation	Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.

Secondary Outcome Measures

Name	Time	Method
Use of allogenic blood transfusions.	In hospital stay (usually 5 to 8 days after operation)	Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Italy