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Platelets Antiaggregation Control Enhancement (PACE) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Cardiochirurgia E.H.
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT01218074
First received: October 5, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Bleeding
Blood Transfusion
Device: Aggregometry+Thromboelastography
Device: Thromboelastography Alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study

Resource links provided by NLM:


Further study details as provided by Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Bleeding Volume [ Time Frame: 12 hours after end of operation ] [ Designated as safety issue: No ]
    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:
  • Use of allogenic blood transfusions. [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ] [ Designated as safety issue: No ]
    Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.


Estimated Enrollment: 400
Study Start Date: December 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Thromboelastography alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.
Device: Thromboelastography Alone
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
Experimental: 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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

  • none.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218074

Contacts
Contact: Luca P Weltert, MD +393478880617 lweltert@gmail.com
Contact: Saverio Nardella, MD save78@virgilio.it

Locations
Italy
European Hospital Recruiting
Rome, Italy, 00149
Contact: Luca P Weltert, MD    +393478880617    lweltert@gmail.com   
Contact: Saverio Nardella, MD       save78@virgilio.it   
Principal Investigator: Luca P Weltert, MD         
Sponsors and Collaborators
Cardiochirurgia E.H.
  More Information

No publications provided

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01218074     History of Changes
Other Study ID Numbers: 00-04
Study First Received: October 5, 2010
Last Updated: February 13, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Cardiochirurgia E.H.:
bleeding
blood sparing procedure
desmopressin
aggregometry
thromboelastography

ClinicalTrials.gov processed this record on November 20, 2014