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

NCT02191839 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-07-16

No results posted yet for this study

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.

Conditions

  • Post Cardiac Surgery Systemic Inflammatory Response

Interventions

DRUG

Alpha 1-Antitrypsin

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • DAN ABRAHAMOV, DR · Soroka University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02191839 on ClinicalTrials.gov