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:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT03074266
Eligibility Criteria:
Inclusion Criteria:
Therapeutic Group
Patients meeting all of the following criteria will be considered for entry into the study:
* Males and females 18 years or older.
* Patients scheduled for elective or urgent procedures requiring anticoagulation with UFH.
* Patients requiring heparin anticoagulant therapy for any approved indication and being managed and monitored with the ACT test.
Exclusion Criteria:
The following criteria define the population of subjects who will not be accepted in the study:
* The subject develops a significant, unexpected, concurrent illness or adverse event before the first whole blood sample is drawn.
* The subject with a hematocrit of less than 20% or greater than 55% since these samples are not recommended for testing due to optical densities outside of the Hemochron instrument levels of detection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03074266
Study Brief:
Protocol Section:
NCT03074266