Platelet Refractoriness in Adult Acute Leukemia
Conditions
Keywords
Prestorage filtered blood, Platelet refractoriness in adult acute leukemia
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))
Interventions
None listed
Sponsors
Siriraj Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Thailand
Contacts
Primary Contactweerapat Owattanapanich, MD
Backup ContactPhakaporn Chamweha, Dr
Outcome results
None listed