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 admissionPercentage 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
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