Overview

Single Dose Administration of Alpha-1 Anti-Trypsin for the Amelioration of Organ Injury in Patients Undergoing Cardiac Surgery

Status:
Unknown status

Trial end date:
2015-07-01

Target enrollment:
0

Participant gender:
All

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 Department of Cardiothoracic Surgery, Soroka University Medical Center. OBJECTIVE To evaluate anti-inflammatory effects, effects on organ function preservation, and postoperative blood loss reduction following AAT-1 administration in patients undergoing CABG with CPB. PRIMARY ENDPOINT Postoperative organ function preservation and blood loss following preoperative single-dose AAT-1 administration. SAMPLE SIZE CONSIDERATIONS A cohort of 20 patients will be recruited. Patients will be randomized to receive either AAT-1 or placebo prior to surgery. Whereas this is a proof of concept pilot study, statistical significance is not the primary objective. INCLUSION CRITERIA 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 CRITERIA Co-existing conditions including: 1. Coagulation abnormalities 2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of less than 60% of predicted. 3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%, 4. Abnormal liver function tests 5. Uncontrolled diabetes mellitus, 6. Severe peripheral vascular disease 7. Prior cerebrovascular neurological event. 8. Abnormal left or right ventricular function. 9. Treatment with warfarin or thienopyridine class of anti platelet agents.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Soroka University Medical Center

Treatments:

Alpha 1-Antitrypsin
Protein C Inhibitor

Criteria

Inclusion Criteria:

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 Criteria:

Co-existing conditions including:

1. Coagulation abnormalities

2. Severe pulmonary disease defined by blood oxygen saturation of 90% or less or FEV1 of
less than 60% of predicted.

3. Renal dysfunction defined be serum creatinine levels higher or equal to 1.8 mg%,

4. Abnormal liver function tests

5. Uncontrolled diabetes mellitus,

6. Severe peripheral vascular disease

7. Prior cerebrovascular neurological event.

8. Abnormal left or right ventricular function.

9. Treatment with warfarin or thienopyridine class of anti platelet agents -