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Study of Administration Of Antithrombin in Patients With Low Plasmatic Levels of Antithrombin After Cardiac Surgery

NCT01201070 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2010-09-15

No results posted yet for this study

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).

Conditions

  • Aortic Valve Insufficiency
  • Aortic Valve Stenosis
  • Mitral Valve Insufficiency
  • Mitral Valve Stenosis
  • Acute Coronary Syndrome

Interventions

DRUG

antithrombin III

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

Sponsors & Collaborators

  • University of Bari

    lead OTHER

Principal Investigators

  • Domenico Paparella, Investigator · Department of Emergency and Organ Transplant, Division of Cardiac Surgery. University of Bari, Italy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Italy

Study Locations

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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 NCT01201070 on ClinicalTrials.gov