Platelet Refractoriness in Adult Acute LeukemiaPTRNCT06325553
Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage Filtered Blood and Comparing With Historical Control
An observational study of Platelet Refractoriness in Adult Acute Leukemia, run by Siriraj Hospital at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Refractoriness in Adult Acute Leukemia
- Type of treatment
- Injection or infusion
- How many people
- 252 participants
- Where
- 1 siteThailand
- Study dates
- 30 Mar 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient 18 years and older who were Newly diagnosed acute leukemia (either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) patients underwent intensive chemotherapy
Who may be able to join
- Case group (PFB transfusion) Inclusion criteria
- Newly diagnosed acute leukemia (either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) patients underwent intensive chemotherapy
- Age greater than 18 years
- Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy
Who cannot join
- 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
- Loss to follow up or death before completion of first consolidation chemotherapy
- Participants receiving granulocyte infusion during time of study
- Historical control group 2 (leukocyte depleted blood product) Inclusion criteria
- Newly diagnosed acute leukemia (either AML or ALL) patients underwent intensive chemotherapy during 2018-2022
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- Age greater than 18 years
- Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Siriraj hospital
Bangkok, 10700
weerapat Owattanapanich, MD, 0891081963, weerapato36733@gmail.com
Phakaporn Chamweha, DR, 06855156615, phakaporn.cham@gmail.com
About this study
Official title: Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage-filtered Blood and Comparing With Historical Control
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
Read the 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))
- Keywords
- Prestorage filtered blood, Platelet refractoriness in adult acute leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 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 | 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 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive statistics
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
Measured: Through study completion and average of 1 year
Inferential statistics
The incidence of platelet refractoriness among each group are represented with percentage and associated 95% confidence interval (CI)
Measured: Through study completion and average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Refractoriness in Adult Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weerapat Owattanapanich, Siriraj Hospital
- Investigators
- weerapat Owattanapanich, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325553
- Sponsor's protocol ID
- 022_2566
- Acronym
- PTR
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Platelet Refractoriness in Adult Acute Leukemia Patients Receiving Prestorage-filtered Blood and Comparing With Historical Control
- ClinicalTrials.gov ID
- NCT06325553
- Acronym / sponsor ID
- PTR / 022_2566
- Keywords
- Prestorage filtered blood, Platelet refractoriness in adult acute leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –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 | – | –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 | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient 18 years and older who were Newly diagnosed acute leukemia (either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) patients underwent intensive chemotherapy
Key inclusion criteria (4 listed)
- Case group (PFB transfusion) Inclusion criteria
- Newly diagnosed acute leukemia (either acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) patients underwent intensive chemotherapy
- Age greater than 18 years
- Participants receiving an induction chemotherapy and at least one cycle of consolidation chemotherapy
Key exclusion criteria (10 listed)
- 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
- Loss to follow up or death before completion of first consolidation chemotherapy
- Participants receiving granulocyte infusion during time of study
- Historical control group 2 (leukocyte depleted blood product) Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive statistics
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Yes. IPD are available from the corresponding author on reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
weerapat Owattanapanich, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Refractoriness in Adult Acute Leukemia, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact weerapat Owattanapanich, MD (0891081963, weerapato36733@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive statistics (time frame: Through study completion and average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.