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Completed

NCT Number: NCT00823082

Use of Antithrombin in 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.

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Key information

Conditions

Acquired Antithrombin III Deficiency Coronary Artery Bypass

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IRCCS Policlinico San Donato

Milan, Lombardy, 20097, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithrombin III

Drug

Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Other names: Anbinex, ATIII

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto Grifols, S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2009
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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