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Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Information source: Grifols Biologicals Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acquired Antithrombin III Deficiency; Coronary Artery Bypass

Intervention: Antithrombin III (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Instituto Grifols, S.A.

Official(s) and/or principal investigator(s):
Marco Ranucci, MD, Principal Investigator, Affiliation: IRCCS Policlinico San Donato, Milano

Overall contact:
Paul J. Pinciaro, PhD, Phone: 4433758825, Email: Paul.Pinciaro@grifols.com

Summary

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% and, eventually, to decrease negative clinical outcomes during the ICU stay.

Clinical Details

Official title: A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Primary outcome:

Postoperative ATIII levels at the ICU admission

Percentage of subjects with ATIII levels of 58% or higher at ICU admission.

Secondary outcome:

Percentage of subjects with postoperative myocardial infarction.

Percentage of subjects with adverse neurologic outcome.

Percentage of patients with thromboembolic events.

ICU stay duration.

In-hospital postoperative mortality

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female

- At least 18 years of age

- Subject needs elective cardiac surgery with cardiopulmonary bypass except for heart

transplantation.

- Subject has a baseline ATIII level of less than 100% and equal to or above 60%.

- HIV, HBV, HCV, HAV and PARVO B19 status known prior to entry.

- Subject has read the patient information and consent form and has agreed to

participate in the trial and signed the consent sheet.

- Subject is willing to comply with all aspects of the protocol, including blood

sampling, for the total duration of the study.

Exclusion Criteria:

- Documented congenital ATIII deficiency or ATIII levels below 60%.

- Subject has a baseline ATIII level of 100% or higher.

- Subject needs emergency (non-elective) surgery.

- Subject needs heart transplantation.

- History of anaphylactic reaction(s) to blood or blood components.

- Allergies to excipients.

- Subject is pregnant.

- Subject has any medical condition that according to the investigators judgment

worsens the surgical outcome above the expected.

- Subject has any medical condition which is likely to interfere with the evaluation of

the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment.

- Subject has participated in any another investigational study within the last 30 days

previous to the inclusion

Locations and Contacts

Paul J. Pinciaro, PhD, Phone: 4433758825, Email: Paul.Pinciaro@grifols.com

IRCCS Policlinico San Donato, Milano, Lombardy 20097, Italy; Recruiting
M. Ranucci, MD, Phone: 02. 52774546, Email: cardioanestesia@virgilio.it
Marco Ranucci, MD, Principal Investigator
Additional Information

Starting date: May 2009
Last updated: March 15, 2010

Page last updated: October 04, 2010

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