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

Siriraj Hospital

Status: Enrolling

Conditions: Platelet Refractoriness in Adult Acute Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT06325553

022_2566

Details and patient eligibility

About

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

Full 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))

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

252 participants in 3 patient groups

1

Description:

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 Withdrawal or termination criteria 1. Loss to follow up or death before completion of first consolidation chemotherapy 2. Participants receiving granulocyte infusion during time of study 3. Participants receiving SDP transfusion during time of study

2

Description:

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

3

Description:

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