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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00039767
Eligibility Criteria:
INCLUSION CRITERIA:
All patients must:
Be greater than or equal to 18 years old.
Be enrolled in protocols at the Clinical Center.
Require tunneled, open-ended VADs for their primary care.
Have their VADs inserted at the Clinical Center in Interventional Radiology.
Intend to receive the majority of their primary medical care at the Clinical Center during the first 4 months after their VAD is inserted.
Have serum creatinine less than or equal to 2.5 mg/dL or a glomerular filtration rate greater than or equal to 50 mL/minute.
Expect to have a platelet count of 70,000/microliter or more without transfusion support for the first 4 weeks of the study anytime that they are not hospitalized.
Have normal blood coagulation. This is defined by either a prothrombin time and aPTT within the laboratory's normal range (11.8-14.7 sec and 23.4-34.5 sec respectively), or by hemostatic coagulation factor levels in patients with prolonged prothrombin times and/or aPTTs that are explained by mild factor VII deficiencies (30-40 %) or by lupus anticoagulants. If a patient has a prolonged aPTT due to a lupus anticoagulant, he/she must have a normal thrombin time in order to be included in the study.
EXCLUSION CRITERIA:
A preference by the primary investigator to use saline flushes for the patient's VAD.
A history of hypersensitivity to heparin, including heparin-induced thrombocytopenia.
(Note that a patient is not excluded simply because he/she has participated in this protocol with a previous VAD or because he/she still has a previously inserted VAD that has been left in place.)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00039767
Study Brief:
Protocol Section:
NCT00039767