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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03712618
Eligibility Criteria:
* INCLUSION CRITERIA:
* Ability to comprehend the investigational nature of the study and provide informed consent
* Thrombocytopenia
* Causes of thrombocytopenia may be due to:
1. Congenital causes
2. Bone marrow
3. Hematologic malignancies
4. Treatment related
* Thrombocytopenia is generally defined as one of the following:
1. Platelet count \<10K/uL without bleeding
2. Platelet count \<20K/uL for "complicated prophylaxis" in patients determined to be at increased risk of bleeding or other complications
3. Platelet count \<50K/uL with evidence of active bleeding, such as intracranial hemorrhage, GI bleeding, pulmonary hemorrhage, uncontrolled epistaxis, hematuria.
The treating provider may change the platelet transfusion threshold based on the clinical circumstance, patient population, and/or concurrent primary protocol considerations - similar to the PLADO study.
* Diagnosed with PTR, characterized by the following:
* Lack of adequate post-transfusion platelet count increment, defined by, Corrected Count Increment (CCI) \<5000/ul at 10-60 min after each of at least 2 consecutive platelet transfusions
* Presence of anti-HLA class 1 type A and/or type B antibody, in the setting of PTR, as defined above, constitutes the HLA alloimmune-mediated subtype of PTR. Presence of one or more HPA antibodies in the setting of PTR, as defined above, constitutes the HPA alloimmune-mediated subtype of PTR. Failure to detect HLA or HPA antibodies will be categorized as non-alloimmune-mediated PTR. .
EXCLUSION CRITERIA:
* Less than 18-years-old
* Lack of ability to obtain informed consent
* Pregnant female
* Presence of ITP/autoimmune thrombocytopenia
* Immune platelet refractoriness responsive to treatment with IVIg or eculizumab, or other immunosuppressive therapy within the 3 preceding months. This is based on the wide variation in the duration therapeutic antibodies, with the upper limit frequently cited as 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03712618
Study Brief:
Protocol Section:
NCT03712618