Clinical Trial: Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Cardiopulmo

Brief 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% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Detailed Summary:
Sponsor: Instituto Grifols, S.A.

Current Primary Outcome:

  • Postoperative ATIII Levels at the ICU Admission [ Time Frame: ICU admission ]
    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 ]
    Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission


Original Primary Outcome:

  • Postoperative ATIII Levels at the ICU Admission [ Time Frame: ICU admission ]
  • Percentage of subjects with ATIII levels of 58% or higher at ICU admission. [ Time Frame: ICU admission ]


Current Secondary Outcome:

  • Percentage of Subjects With Postoperative Myocardial Infarction [ Time Frame: During ICU stay (maximum 70 days) ]
    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) ]
    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) ]
    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) ]
  • In-hospital Postoperative Mortality [ Time Frame: 70 days after ICU admission (maximum) ]
  • Heparin Resistance [ Time Frame: Immediately after anesthesia induction ]
    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 ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
  • Length of Hospital Stay [ Time Frame: During ICU stay (maximum 70 days) ]
    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.


Original Secondary Outcome:

  • Percentage of subjects with postoperative myocardial infarction. [ Time Frame: One month ]
  • Percentage of subjects with adverse neurologic outcome. [ Time Frame: One month ]
  • Percentage of patients with thromboembolic events. [ Time Frame: One month ]
  • ICU stay duration. [ Time Frame: One month (maximum) ]
  • In-hospital Postoperative Mortality [ Time Frame: One month (maximum) ]


Information By: Grifols Biologicals Inc.

Dates:
Date Received: January 14, 2009
Date Started: June 2009
Date Completion:
Last Updated: August 10, 2016
Last Verified: August 2016