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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01201070 |
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Date of registration:
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08/09/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery
ATIII |
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Scientific title:
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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 |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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90 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01201070 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Domenico Paparella, MD |
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Address:
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Telephone:
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+39 080 559 5075 |
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Email:
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dpaparella@cardiochir.uniba.it |
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Affiliation:
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Name:
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Paparella, MD |
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Address:
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Telephone:
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Email:
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dpaparella@cardiochir.uniba.it |
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Affiliation:
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Name:
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Domenico Paparella, Investigator |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aortic Valve Stenosis
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Acute Coronary Syndrome
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Mitral Valve Insufficiency
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Mitral Valve Stenosis
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Aortic Valve Insufficiency
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Intervention(s)
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Drug: antithrombin III
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Number of participants with multi organ failure as a measure of safety.
[Time Frame: until 5 days after surgery]
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Number of participants with wound complication as a measure of safety.
[Time Frame: until 5 days after surgery]
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Number of participants with delirium as a measure of safety.
[Time Frame: until 5 days after surgery]
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Number of participants with infection as a measure of safety.
[Time Frame: until 5 days after surgery]
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Secondary ID(s)
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Antithrombin III
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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