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Platelets Antiaggregation Control Enhancement (PACE) Study (PACE)

Primary Purpose

Bleeding, Blood Transfusion

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Aggregometry+Thromboelastography
Thromboelastography Alone
Sponsored by
Cardiochirurgia E.H.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bleeding focused on measuring bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • all patients undergoing surgical myocardial revascularization.

Exclusion Criteria:

  • none.

Sites / Locations

  • European Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Thromboelastography alone

Aggregometry+Tromboelastography

Arm Description

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

Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.

Outcomes

Primary Outcome Measures

Bleeding Volume
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.
Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.

Full Information

First Posted
October 5, 2010
Last Updated
January 24, 2018
Sponsor
Cardiochirurgia E.H.
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1. Study Identification

Unique Protocol Identification Number
NCT01218074
Brief Title
Platelets Antiaggregation Control Enhancement (PACE) Study
Acronym
PACE
Official Title
Platelets Antiaggregation Control Enhancement Study: an Independent Randomized Blind Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardiochirurgia E.H.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Blood Transfusion
Keywords
bleeding, blood sparing procedure, desmopressin, aggregometry, thromboelastography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thromboelastography alone
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performances.
Arm Title
Aggregometry+Tromboelastography
Arm Type
Experimental
Arm Description
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Intervention Type
Device
Intervention Name(s)
Aggregometry+Thromboelastography
Intervention Description
Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
Intervention Type
Device
Intervention Name(s)
Thromboelastography Alone
Intervention Description
Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
Primary Outcome Measure Information:
Title
Bleeding Volume
Description
Total amount of bleeding in the first 12 hours after cardiac surgery expressed as milliliters of blood in the chest drains reservoir.
Time Frame
12 hours after end of operation
Secondary Outcome Measure Information:
Title
Use of allogenic blood transfusions.
Description
Number of allogenic blood units transfused per patients during the full hospital stay, usually 5 to 8 days after operation.
Time Frame
In hospital stay (usually 5 to 8 days after operation)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all patients undergoing surgical myocardial revascularization. Exclusion Criteria: none.
Facility Information:
Facility Name
European Hospital
City
Rome
ZIP/Postal Code
00149
Country
Italy

12. IPD Sharing Statement

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