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Platelets Antiaggregation Control Enhancement (PACE) Study

Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01218074
Acronym
PACE
Enrollment
200
Registered
2010-10-11
Start date
2010-12-31
Completion date
2017-09-30
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Blood Transfusion

Keywords

bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography

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.

Interventions

DEVICEAggregometry+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.

DEVICEThromboelastography Alone

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

Sponsors

Cardiochirurgia E.H.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* all patients undergoing surgical myocardial revascularization.

Exclusion criteria

* none.

Design outcomes

Primary

MeasureTime frameDescription
Bleeding Volume12 hours after end of operationTotal amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.

Secondary

MeasureTime frameDescription
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026