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: October 18, 2011
Last verified: October 2011
  Purpose

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% and, eventually, to decrease negative clinical outcomes during the ICU stay.


Condition Intervention Phase
Acquired Antithrombin III Deficiency
Coronary Artery Bypass
Drug: Antithrombin III
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Grifols Biologicals Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: May 2009
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment group
Preoperative ATIII supplementation
Drug: Antithrombin III
Single dose of antithrombin III sufficient to achieve a level of 120%
Other Names:
  • Anbinex
  • ATIII
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • At least 18 years of age
  • Subject needs elective cardiac surgery with cardiopulmonary bypass except for heart transplantation.
  • Subject has a baseline ATIII level of less than 100% and equal to or above 60%.
  • HIV, HBV, HCV, HAV and PARVO B19 status known prior to entry.
  • Subject has read the patient information and consent form and has agreed to participate in the trial and signed the consent sheet.
  • Subject is 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 has a baseline ATIII level of 100% or higher.
  • Subject needs emergency (non-elective) surgery.
  • Subject needs heart transplantation.
  • History of anaphylactic reaction(s) to blood or blood components.
  • Allergies to excipients.
  • Subject is pregnant.
  • Subject has any medical condition that according to the investigators judgment worsens the surgical outcome above the expected.
  • Subject has 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 has participated in any another investigational study within the last 30 days previous to the inclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823082

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

No publications provided by Grifols Biologicals Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Grifols Biologicals Inc. ( Instituto Grifols, S.A. )
ClinicalTrials.gov Identifier: NCT00823082     History of Changes
Other Study ID Numbers: IG0801
Study First Received: January 14, 2009
Last Updated: October 18, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Grifols Biologicals Inc.:
antithrombin
ATIII
acquired deficiency
anticoagulants
cardiopulmonary bypass
surgery
complications
postoperative outcomes

Additional relevant MeSH terms:
Antithrombin III Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Thrombophilia
Genetic Diseases, Inborn
Antithrombins
Antithrombin Proteins
Antithrombin III
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014