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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


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


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


Inclusion Criteria:

- Male or female

- At least 18 years of age

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


- 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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