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Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT00823082
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : August 4, 2016
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acquired Antithrombin III Deficiency Coronary Artery Bypass Drug: Antithrombin III Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Study Start Date : June 2009
Primary Completion Date : June 2011
Study Completion Date : September 2011

Arms and Interventions

Arm Intervention/treatment
Experimental: Antithrombin III treatment group
Preoperative ATIII supplementation administered immediately after anesthesia induction
Drug: Antithrombin III
Single dose of antithrombin III sufficient to achieve a preoperative level of 120%
Other Names:
  • Anbinex
No Intervention: Control group
No preoperative ATIII supplementation administered

Outcome Measures

Primary Outcome Measures :
  1. Postoperative ATIII Levels at the ICU Admission [ Time Frame: ICU admission ]
    Measurement of postoperative ATIII functional activity at ICU admission

  2. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. ICU Stay Duration [ Time Frame: During ICU stay (maximum 70 days) ]
  5. In-hospital Postoperative Mortality [ Time Frame: 70 days after ICU admission (maximum) ]
  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Mechanical Ventilation Duration [ Time Frame: During ICU stay (maximum 70 days) ]
  13. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823082

IRCCS Policlinico San Donato
Milano, Lombardy, Italy, 20097
Sponsors and Collaborators
Instituto Grifols, S.A.
Principal Investigator: Marco Ranucci, MD IRCCS Policlinico San Donato, Milano
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Instituto Grifols, S.A.
ClinicalTrials.gov Identifier: NCT00823082     History of Changes
Other Study ID Numbers: IG0801
First Posted: January 15, 2009    Key Record Dates
Results First Posted: August 4, 2016
Last Update Posted: September 20, 2016
Last Verified: August 2016

Keywords provided by Grifols Biologicals Inc. ( Instituto Grifols, S.A. ):
acquired deficiency
cardiopulmonary bypass
postoperative outcomes

Additional relevant MeSH terms:
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Genetic Diseases, Inborn
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action