Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery (ATIII)
Primary Purpose
Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
antithrombin III
Sponsored by
About this trial
This is an interventional supportive care trial for Aortic Valve Insufficiency
Eligibility Criteria
Inclusion Criteria:
- All patients were candidates for cardiac surgery intervention in extracorporeal circulation
Exclusion Criteria:
- positive history for allergic reactions to AT III
- cardiac surgery "Off-Pump"
- administration of AT during surgery or within 48 h
- treatment with drugs and non-steroidal steroids within 48 h prior
- disorders of coagulation
- platelets <30,000
- pre-existing IRC in dialysis treatment
- severe liver failure
- enlistment in another trial in the last 30 days
- hypothermia
- emergency
- reopening
- length of CEC> 180 minutes
- subjects incapable of giving legal consent
Sites / Locations
- Azienda Ospedaliero-Universitaria PoliclinicoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Active Comparator
Arm Label
control group
no treatment
TREATMENT WITH ANTITHROMBIN
Arm Description
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
Outcomes
Primary Outcome Measures
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
Secondary Outcome Measures
Number of participants with infection as a measure of safety.
Number of participants with delirium as a measure of safety.
Number of participants with wound complication as a measure of safety.
Number of participants with multi organ failure as a measure of safety.
Full Information
NCT ID
NCT01201070
First Posted
September 8, 2010
Last Updated
September 14, 2010
Sponsor
University of Bari
1. Study Identification
Unique Protocol Identification Number
NCT01201070
Brief Title
Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Acronym
ATIII
Official Title
Effects of the Administration Of Antithrombin on the Coagulation Status and on the Inflammatory Response in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
November 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bari
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
General and specific objectives of the search: evaluate the effects of the administration of Antithrombin III (ATIII) on the activation of the coagulation system and of the fibrinolysis, platelet function, inflammatory response and markers of organ damage in patients undergoing cardiac surgery by cardiopulmonary bypass (CPB) with low plasma levels of post-operative Antithrombin (AT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Insufficiency, Aortic Valve Stenosis, Mitral Valve Insufficiency, Mitral Valve Stenosis, Acute Coronary Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Title
no treatment
Arm Type
No Intervention
Arm Title
TREATMENT WITH ANTITHROMBIN
Arm Type
Active Comparator
Arm Description
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
Intervention Type
Drug
Intervention Name(s)
antithrombin III
Intervention Description
3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
Primary Outcome Measure Information:
Title
Number of participants with reduced bleeding, transfusion requirements and need of reintervention for bleeding as a measure of efficacy.
Time Frame
until 5 days after surgey
Secondary Outcome Measure Information:
Title
Number of participants with infection as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with delirium as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with wound complication as a measure of safety.
Time Frame
until 5 days after surgery
Title
Number of participants with multi organ failure as a measure of safety.
Time Frame
until 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients were candidates for cardiac surgery intervention in extracorporeal circulation
Exclusion Criteria:
positive history for allergic reactions to AT III
cardiac surgery "Off-Pump"
administration of AT during surgery or within 48 h
treatment with drugs and non-steroidal steroids within 48 h prior
disorders of coagulation
platelets <30,000
pre-existing IRC in dialysis treatment
severe liver failure
enlistment in another trial in the last 30 days
hypothermia
emergency
reopening
length of CEC> 180 minutes
subjects incapable of giving legal consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico Paparella, MD
Phone
+39 080 559 5075
Email
dpaparella@cardiochir.uniba.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico Paparella, Investigator
Organizational Affiliation
Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paparella, MD
Email
dpaparella@cardiochir.uniba.it
First Name & Middle Initial & Last Name & Degree
Crescenzia Rotunno, BSc
12. IPD Sharing Statement
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Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
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