Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass
This study has been completed.
Sponsor:
Instituto Grifols, S.A.
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
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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:
Genetics Home Reference related topics:
factor V Leiden thrombophilia
hereditary antithrombin deficiency
prothrombin thrombophilia
U.S. FDA Resources
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:
|
| 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 More Information
No publications provided
| 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 III |
Antithrombin Proteins 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 May 23, 2013