Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control

Recruiting

• Conditions: Platelet Refractoriness in Adult Acute Leukemia

• Registration Number: NCT06325553
• Lead Sponsor: Siriraj Hospital

Brief Summary

This research project is evaluate the incidence of platelet refractoriness in newly diagnosed acute leukemia patients receiving PFB during induction and first consolidation phase chemotherapy compared to 2 historical control groups which are patients receiving non-leukocyte depleted blood product group and leukocyte depleted blood product group and demonstrate cost-effectiveness of using blood products with filtered process to prevent clinical platelet refractoriness compare with using HLA-matched blood products after platelet refractoriness occurs

Detailed Description

This study the objective is to study and compare the incidence of Platelet Refractoriness. of the group that received PFB blood compared to the group that received LPPC/LPB blood in the past in patients with AML and ALL at Siriraj Hospital From the literature review, it was found that the incidence of Platelet Refractoriness of the group receiving LPPC/LPB blood in patients with AML and ALL was 46% and the incidence of Platelet Refractoriness Of the group receiving PFB blood in AML and ALL patients, it was 11% .But from the collection of blood bank data Siriraj Hospital during 2020-2021 found that the incidence of Platelet Refractoriness in AML and ALL patients who received PFB blood was approximately 27%. The researchers estimated that In this study There may be an incidence of Platelet Refractoriness. of the group receiving PFB blood in patients with AML and ALL was as high as 27%, and when determining the sample size in the group receiving LPPC/LPB blood, it was 2 times greater than the group receiving PFB blood and setting the standard value according to the table Z equal to 1.96 and The power of the test is 80% when the sample size is calculated with the formula Comparing the proportion values between two independent populations (Testing two independent proportion: Formula (without continuity correlation))

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-22
• Last Update Posted: 2024-03-22
• Study Start: 2024-03-30
• Primary Completion: 2025-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

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

5. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inferential statistics	Through study completion and average of 1 year	The incidence of platelet refractoriness among each group are represented with percentage and associated 95% confidence interval (CI)
Descriptive statistics	Through study completion and average of 1 year	Qualitative variables (e.g. sex, underlying diseases) are presented as the frequency and percentage. Quantitative variables (e.g. age at diagnosis, follow-up time) are presented as mean and standard deviation if the data is normally distributed. Median and range are presented instead if the data is not normally distributed

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand