Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325553
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-15
Brief Title:
Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control
Sponsor:
Siriraj Hospital
Organization:
Siriraj Hospital
Study Overview
Official Title:
Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage-filtered Blood and Comparing With Historical Control
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTR
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 LPPCLPB 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 LPPCLPB 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 LPPCLPB blood it was 2 times greater than the group receiving PFB blood and setting the standard value according to the table Z equal to 196 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None