Evaluating platelet refractoriness in acute leukemia patients receiving filtered blood
Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage-filtered Blood and Comparing With Historical Control
This study is testing whether using filtered blood products can help newly diagnosed acute leukemia patients avoid problems with their platelets during chemotherapy compared to those who received regular blood products.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Siriraj Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT06325553 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving prestorage filtered blood (PFB) during their induction and first consolidation chemotherapy. It compares the outcomes of these patients with historical control groups who received non-leukocyte depleted blood products and leukocyte depleted blood products. The study will analyze data from Siriraj Hospital to determine the effectiveness and cost-effectiveness of using filtered blood products to prevent clinical platelet refractoriness. The researchers will calculate sample sizes based on previous incidence rates to ensure robust statistical analysis.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are newly diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) and are undergoing intensive chemotherapy.
Not a fit: Patients with positive platelet antibodies detected at presentation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of platelet refractoriness in acute leukemia patients, enhancing their treatment outcomes.
How similar studies have performed: Previous studies have indicated varying success rates with different blood product types, but this specific comparison of prestorage filtered blood against historical controls is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Case group (PFB transfusion) Inclusion criteria 1. Newly diagnosed acute leukemia (either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) patients underwent intensive chemotherapy 2. Age greater than 18 years 3. Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy Exclusion Criteria: 1. Participants with positive platelet antibody detected by SPRCA method at presentation Historical control group 1 (non-leukocyte depleted blood product) Inclusion criteria 1.Newly diagnosed acute leukemia (either AML or ALL) patients underwent intensive chemotherapy during 2018-2022 2. Age greater than 18 years 3. Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy 4. Participants receiving only non-leukocyte depleted blood products (LPB and LPPC) Exclusion criteria 1. Loss to follow up or death before completion of first consolidation chemotherapy 2. Participants receiving granulocyte infusion during time of study Historical control group 2 (leukocyte depleted blood product) Inclusion criteria 1. Newly diagnosed acute leukemia (either AML or ALL) patients underwent intensive chemotherapy during 2018-2022 2. Age greater than 18 years 3. Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy 4. Participants receiving leukocyte depleted blood products (PFB and SDP) Exclusion criteria 1. Loss to follow up or death before completion of first consolidation chemotherapy during 2018-2022 2. Participants receiving granulocyte infusion during time of study 3. Participants receiving non-leukocyte depleted blood products greater than 20% of all transfused blood products during induction and first consolidation chemotherapy
Where this trial is running
Bangkok
- Siriraj hospital — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: weerapat Owattanapanich, MD — Siriraj Hospital
- Study coordinator: weerapat Owattanapanich, MD
- Email: weerapato36733@gmail.com
- Phone: 0891081963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.