Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier:
NCT00823082
First received: January 14, 2009
Last updated: October 18, 2011
Last verified: October 2011

January 14, 2009
October 18, 2011
May 2009
July 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00823082 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Acquired Antithrombin III Deficiency
  • Coronary Artery Bypass
Drug: Antithrombin III
Single dose of antithrombin III sufficient to achieve a level of 120%
Other Names:
  • Anbinex
  • ATIII
  • Experimental: Treatment group
    Preoperative ATIII supplementation
    Intervention: Drug: Antithrombin III
  • No Intervention: Control group
Ranucci M, Baryshnikova E, Crapelli GB, Woodward MK, Paez A, Pelissero G. Preoperative antithrombin supplementation in cardiac surgery: a randomized controlled trial. J Thorac Cardiovasc Surg. 2013 May;145(5):1393-9. doi: 10.1016/j.jtcvs.2012.09.061. Epub 2012 Oct 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
September 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00823082
IG0801
No
Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
Instituto Grifols, S.A.
Not Provided
Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato, Milano
Grifols Biologicals Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP