Platelets Antiaggregation Control Enhancement (PACE) Study

Bleeding Clinical Trial

— PACE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01218074
• Other study ID #: 00-04
• Status: Terminated
• Phase: N/A
• First received: October 5, 2010
• Last updated: January 24, 2018
• Start date: December 2010
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

Related Conditions & MeSH terms

• Bleeding
• Blood Transfusion
• Hemorrhage

Intervention

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

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Use of allogenic blood transfusions.	Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.	In hospital stay (usually 5 to 8 days after operation)