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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: August 10, 2016
Last verified: August 2016

January 14, 2009
August 10, 2016
June 2009
June 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 ]
    Measurement of postoperative ATIII functional activity at ICU admission
  • Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission [ Time Frame: ICU admission ] [ Designated as safety issue: No ]
    Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
  • 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 ]
Complete list of historical versions of study NCT00823082 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With Postoperative Myocardial Infarction [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram
  • Percentage of Subjects With Adverse Neurologic Outcome [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation
  • Percentage of Patients With Thromboembolic Events [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
  • ICU Stay Duration [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
  • In-hospital Postoperative Mortality [ Time Frame: 70 days after ICU admission (maximum) ] [ Designated as safety issue: Yes ]
  • Heparin Resistance [ Time Frame: Immediately after anesthesia induction ] [ Designated as safety issue: No ]
    Percentage of subjects with heparin resistance defined as failure to reach an activated clotting time >450 seconds after a dose of up to 400 IU/kg of heparin, or failure to maintain this activated clotting time value despite heparin supplementations of 100 IU/kg per each dose with an interval of at least 30 minutes between doses
  • Postoperative Blood Loss in First 12 Hours [ Time Frame: ICU admission through 12 hours post-operative ] [ Designated as safety issue: Yes ]
    Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours
  • Need for Blood Products [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
  • Percentage of Subjects Needing Surgical Re-exploration [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects needing surgical re-exploration resulting from bleeding
  • Percentage of Subjects With Low Cardiac Syndrome [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump
  • Percentage of Subjects With Renal Dysfunction [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
    Percentage of subjects with renal dysfunction defined as an increase of serum creatinine levels to >2.0 and twice the baseline level or need for renal replacement therapy
  • Mechanical Ventilation Duration [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: Yes ]
  • Length of Hospital Stay [ Time Frame: During ICU stay (maximum 70 days) ] [ Designated as safety issue: No ]
    Length of hospital stay (days) in both groups was defined as the discharge date minus the surgery date plus 1 day, during a maximum of 70 days after ICU admission.
  • 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 ]
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% of functional activity 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 preoperative level of 120%
Other Names:
  • Anbinex
  • ATIII
  • Experimental: Antithrombin III treatment group
    Preoperative ATIII supplementation administered immediately after anesthesia induction
    Intervention: Drug: Antithrombin III
  • No Intervention: Control group
    No preoperative ATIII supplementation administered
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.

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

Inclusion Criteria:

  • Male or female
  • At least 18 years of age
  • Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation
  • Subject had a baseline ATIII level of less than 100% and equal to or above 60%
  • Subject signed the informed consent form
  • Subject was 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 had a baseline ATIII level of 100% or higher
  • Subject needed emergency (non-elective) surgery
  • Subject needed heart transplantation
  • History of anaphylactic reaction(s) to blood or blood components
  • Allergies to excipients
  • Subject was pregnant
  • Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected
  • Subject had 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 had participated in any another investigational study within the last 30 days previous to the inclusion
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00823082
IG0801
No
Not Provided
Not Provided
Instituto Grifols, S.A.
Instituto Grifols, S.A.
Not Provided
Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato, Milano
Grifols Biologicals Inc.
August 2016

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