Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
This study has been completed.
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
First received: January 14, 2009
Last updated: October 18, 2011
Last verified: October 2011
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.
Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Drug: Antithrombin III
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
||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
Primary Outcome Measures:
- Postoperative ATIII levels at the ICU admission [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
- Percentage of subjects with ATIII levels of 58% or higher at ICU admission. [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of subjects with postoperative myocardial infarction. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
- Percentage of subjects with adverse neurologic outcome. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
- Percentage of patients with thromboembolic events. [ Time Frame: One month ] [ Designated as safety issue: Yes ]
- ICU stay duration. [ Time Frame: One month (maximum) ] [ Designated as safety issue: Yes ]
- In-hospital postoperative mortality [ Time Frame: One month (maximum) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2011 (Final data collection date for primary outcome measure)
Experimental: Treatment group
Preoperative ATIII supplementation
Drug: Antithrombin III
Single dose of antithrombin III sufficient to achieve a level of 120%
No Intervention: Control group
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823082
|IRCCS Policlinico San Donato
|Milano, Lombardy, Italy, 20097 |
Instituto Grifols, S.A.
||Marco Ranucci, MD
||IRCCS Policlinico San Donato, Milano
No publications provided
||Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 14, 2009
||October 18, 2011
||Italy: The Italian Medicines Agency
Keywords provided by Grifols Biologicals Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Blood Protein Disorders
Genetic Diseases, Inborn
Serine Proteinase Inhibitors
Molecular Mechanisms of Pharmacological Action