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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT05549232
Eligibility Criteria:
Inclusion Criteria:
A. Hematological malignancies patients group:
1. Male or female patients at least 18 years of age
2. Patients expected to require \> 2 units of red blood cells in a single transfusion event
3. Patients who have the capacity to consent to participate and are willing to comply with the study procedures.
4. Patients identified by a Transfusion hemoglobin trigger of less than 9 g/dL
5. Patients with a documented diagnosis of leukemia, myelomatosis or MDS requiring chronic transfusions
B. Burn patients group:
1. Male or female patients at least 18 years of age
2. Patients who have the capacity to consent by themselves to participate to the clinical investigation
3. Smaller burn patients, hospitalized with a Total Body Surface Area (TBSA%) burn ≥ 10% and ≤ 50%
4. Patients expected to require \> 2 unit of red blood cells in a single transfusion event
Exclusion Criteria:
A. Both patients groups
1. Patients with any positive antibody screening test
2. Patients for whom consent has not been obtained
3. Patients with a known hemolytic anemia (congenital or acquired)
4. Patients \< 18 years old
5. Patients with a known or suspected pregnancy
6. Patients with a history of major transfusion reactions
7. Patients whom the Investigator deems clinical trial participation is not in their best interest.
B. Burn patients specific exclusion criteria :
1. Patients who do not have the capacity to consent by themselves to participate to the clinical investigation
2. Patients hospitalized with a Total body surface area (TBSA%) burn more than 50%
3. Patients with combined trauma in need of blood transfusions for treatment other than the burn excision
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05549232
Study Brief:
Protocol Section:
NCT05549232