Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT01698567
Eligibility Criteria:
Inclusion Criteria:
* Subjects will be included if they are presenting for elective cardiac surgery using cardiopulmonary bypass and are 180 days of age or less.
Exclusion Criteria:
Sensitivity to ATIII product (Thrombate, Grifols, Los Angeles, CA)
* Known inherited or acquired coagulation defect
* Current or prior treatment with pro-or anticoagulant medication within past 30 days (except aspirin or a single dose of heparin, e.g. for catheterization)
* Known central venous thrombosis
* Recent (30 days) transfusion with hemostatic blood products (fresh-frozen plasma, platelets, cryoprecipitate, whole blood)
* wt less than 3000g
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
180 Days
Study:
NCT01698567
Study Brief:
Protocol Section:
NCT01698567