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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT02298933
Eligibility Criteria:
* INCLUSION CRITERIA:
* Ages 18-75 years inclusive.
* Ability to comprehend the investigational nature of the study and provide informed consent.
* Thrombocytopenia (due to congenital causes, bone marrow failure, hematologic malignancies, and treatment related), defined as \<10k/uL without bleeding or \<30K/uL with evidence of life threatening bleeding (intracranial hemorrhage, GI bleeding, pulmonary hemorrhage, uncontrolled epistaxis, hematuria).
* Diagnosed with immune platelet refractoriness, characterized by all of the following:
* Lack of adequate post-transfusion platelet count increment, defined by, CCI \<7500/ul at 10-60 min, and CCI \<5000/ul at 18-24 hrs (in those who had a CCI at 10-60 min greater than or equal to 5000/microl)after at least 2 consecutive transfusions.
* Presence of anti-HLA class A and/or B antibody.
EXCLUSION CRITERIA:
* Active meningococcal infection.
* Severe psychiatric illness. Mental deficiency sufficiently severe as to make making informed consent impossible.
* Positive pregnancy test for women of childbearing age within 1 week.
* HIV positive test within 3 months
* Paroxysmal Nocturnal Hemoglobinuria (PNH) disease with evidence of intravascular hemolysis.
* Presence ITP/autoimmune thrombocytopenia
* Immune platelet refractoriness responsive to treatment with IVIG
RE-ENROLLMENT CRITERIA:
* Meet response criteria to the initial treatment or second treatment
* Meets all initial inclusion/exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02298933
Study Brief:
Protocol Section:
NCT02298933