Status:
UNKNOWN
Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Soroka University Medical Center
Conditions:
Post Cardiac Surgery Systemic Inflammatory Response
Eligibility:
All Genders
40-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Protocol Summary STUDY DESIGN A pilot, prospective, double blind, randomized, placebo controlled study. STUDY POPULATION Patients assigned to elective CABG with cardiopulmonary bypass (CPB) at the De...
Detailed Description
3 Background The use of cardiopulmonary bypass (CPB) during cardiac surgery elicits generalized non-specific systemic inflammatory response syndrome (SIRS) and subsequent activation of the cytokine, c...
Eligibility Criteria
Inclusion
- 1\. The study population will comprise patients between 40 and 70 years of age, irrespective of gender, at low or intermediate operative risk (calculated Logistic Euroscore stratification of 5% or less), assigned to elective CABG with CPB. Recruitment depending on patients informed consent.
Exclusion
- Co-existing conditions including:
- Coagulation abnormalities
- Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of less than 60% of predicted.
- Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,
- Abnormal liver function tests
- Uncontrolled diabetes mellitus,
- Severe peripheral vascular disease
- Prior cerebrovascular neurological event.
- Abnormal left or right ventricular function.
- Treatment with warfarin or thienopyridine class of anti platelet agents -
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02191839
Start Date
July 1 2014
End Date
July 1 2015
Last Update
July 16 2014
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