Platelets Antiaggregation Control Enhancement (PACE) Study
PACE
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
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
First Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 11, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedJanuary 26, 2018
January 1, 2018
5.8 years
October 5, 2010
January 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bleeding Volume
Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.
12 hours after end of operation
Secondary Outcomes (1)
Use of allogenic blood transfusions.
In hospital stay (usually 5 to 8 days after operation)
Study Arms (2)
Thromboelastography alone
ACTIVE COMPARATORPatients undergo standard of care Thromboelastography to evaluate overall coagulation performances.
Aggregometry+Tromboelastography
EXPERIMENTALPatients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Interventions
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
Eligibility Criteria
You may qualify if:
- all patients undergoing surgical myocardial revascularization.
You may not qualify if:
- none.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
European Hospital
Rome, 00149, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Project Leader Luca Weltert
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 11, 2010
Study Start
December 1, 2010
Primary Completion
September 1, 2016
Study Completion
September 1, 2017
Last Updated
January 26, 2018
Record last verified: 2018-01