Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Coronary Artery Bypass Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823082
• Other study ID #: IG0801
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2009
• Last updated: October 18, 2011
• Start date: May 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Grifols Biologicals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acquired Antithrombin III Deficiency
• Antithrombin III Deficiency
• Coronary Artery Bypass

Intervention

Drug:
• Antithrombin III
Single dose of antithrombin III sufficient to achieve a level of 120%

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	Milano	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Grifols, S.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative ATIII levels at the ICU admission		ICU admission	No
Primary	Percentage of subjects with ATIII levels of 58% or higher at ICU admission.		ICU admission	No
Secondary	Percentage of subjects with postoperative myocardial infarction.		One month	Yes
Secondary	Percentage of subjects with adverse neurologic outcome.		One month	Yes
Secondary	Percentage of patients with thromboembolic events.		One month	Yes
Secondary	ICU stay duration.		One month (maximum)	Yes
Secondary	In-hospital postoperative mortality		One month (maximum)	Yes