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Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Primary Purpose

Acquired Antithrombin III Deficiency, Coronary Artery Bypass

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Antithrombin III
Sponsored by
Instituto Grifols, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acquired Antithrombin III Deficiency focused on measuring antithrombin, ATIII, acquired deficiency, anticoagulants, cardiopulmonary bypass, surgery, complications, postoperative outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Policlinico San Donato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antithrombin III treatment group

Control group

Arm Description

Preoperative ATIII supplementation administered immediately after anesthesia induction

No preoperative ATIII supplementation administered

Outcomes

Primary Outcome Measures

Postoperative ATIII Levels at the ICU Admission
Measurement of postoperative ATIII functional activity at ICU admission
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission

Secondary Outcome Measures

Percentage of Subjects With Postoperative Myocardial Infarction
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
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
Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
ICU Stay Duration
In-hospital Postoperative Mortality
Heparin Resistance
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
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
Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
Percentage of Subjects Needing Surgical Re-exploration
Percentage of subjects needing surgical re-exploration resulting from bleeding
Percentage of Subjects With Low Cardiac Syndrome
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
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
Length of Hospital Stay
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.

Full Information

First Posted
January 14, 2009
Last Updated
August 10, 2016
Sponsor
Instituto Grifols, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00823082
Brief Title
Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Grifols, S.A.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Antithrombin III Deficiency, Coronary Artery Bypass
Keywords
antithrombin, ATIII, acquired deficiency, anticoagulants, cardiopulmonary bypass, surgery, complications, postoperative outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antithrombin III treatment group
Arm Type
Experimental
Arm Description
Preoperative ATIII supplementation administered immediately after anesthesia induction
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No preoperative ATIII supplementation administered
Intervention Type
Drug
Intervention Name(s)
Antithrombin III
Other Intervention Name(s)
Anbinex, ATIII
Intervention Description
Single dose of antithrombin III sufficient to achieve a preoperative level of 120%
Primary Outcome Measure Information:
Title
Postoperative ATIII Levels at the ICU Admission
Description
Measurement of postoperative ATIII functional activity at ICU admission
Time Frame
ICU admission
Title
Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission
Description
Percentage of subjects with ATIII levels of 58% functional activity or higher at ICU admission
Time Frame
ICU admission
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Postoperative Myocardial Infarction
Description
Percentage of subjects with postoperative myocardial infarction defined through enzymatic criteria plus new Q-waves at the electrocardiogram
Time Frame
During ICU stay (maximum 70 days)
Title
Percentage of Subjects With Adverse Neurologic Outcome
Description
Percentage of subjects with adverse neurologic outcome defined as: coma, stroke or psychotic behaviors lasting >12 hours after extubation
Time Frame
During ICU stay (maximum 70 days)
Title
Percentage of Patients With Thromboembolic Events
Description
Percentage of subjects with thromboembolic events defined as perioperative myocardial infarction, stroke, mesenteric infarction, peripheral thromboembolism and pulmonary embolism
Time Frame
During ICU stay (maximum 70 days)
Title
ICU Stay Duration
Time Frame
During ICU stay (maximum 70 days)
Title
In-hospital Postoperative Mortality
Time Frame
70 days after ICU admission (maximum)
Title
Heparin Resistance
Description
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
Time Frame
Immediately after anesthesia induction
Title
Postoperative Blood Loss in First 12 Hours
Description
Blood loss defined as the amount of blood collected in the cardiotomy reservoir from ICU admission through the following 12 hours
Time Frame
ICU admission through 12 hours post-operative
Title
Need for Blood Products
Description
Number of units of packed red blood cells, fresh frozen plasma, and/or platelets needed
Time Frame
During ICU stay (maximum 70 days)
Title
Percentage of Subjects Needing Surgical Re-exploration
Description
Percentage of subjects needing surgical re-exploration resulting from bleeding
Time Frame
During ICU stay (maximum 70 days)
Title
Percentage of Subjects With Low Cardiac Syndrome
Description
Percentage of subjects with low cardiac syndrome defined as the need for major inotropic support or intra-aortic balloon pump
Time Frame
During ICU stay (maximum 70 days)
Title
Percentage of Subjects With Renal Dysfunction
Description
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
Time Frame
During ICU stay (maximum 70 days)
Title
Mechanical Ventilation Duration
Time Frame
During ICU stay (maximum 70 days)
Title
Length of Hospital Stay
Description
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.
Time Frame
During ICU stay (maximum 70 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Ranucci, MD
Organizational Affiliation
IRCCS Policlinico San Donato, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico San Donato
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20097
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23102903
Citation
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.
Results Reference
derived

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Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

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