Platelet Storage Lesion(PSL)NCT05144074
Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates
An observational study of Platelet Storage Lesion(PSL), run by Assiut University.
Trial summary
The aim of this study to assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Platelet Storage Lesion(PSL)
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to Mar 2025
- 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 to 60 years
- All sexes
- Adult
Study population: All gender fullfilling inclusion criteria are participating in this study ,
Who may be able to join
- Donors who met criteria of Egyptian National Transfusion services
- Donors who had not taken any antiplatelet drugs for two weeks prior to donation
- pre-collection platelet count ≥200×109 /L.
- Blood grouping.
- Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).
Who cannot join
- Donors who not met criteria of Egyptian National Transfusion services
- Donors who had taken any antiplatelet drugs for two weeks prior to donation
- pre-collection platelet count <200×109 /L.
- Reactive serology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: CD62P(P-selectin) as a Marker of Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates
The aim of this study to assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .
Read the detailed description
Platelet transfusion is a lifesaving procedure that is carried out to prevent bleeding or stop ongoing bleeding in patients with low platelet count or functional platelet disorders. There are minimum thresholds at which platelets are transfused in these patients, as not all low levels of platelet warrants a transfusion. Platelet is a scarce resource as processing, preparing, and transfusing it requires a great deal of precision and effort to maintain a certain quality. This activity highlights the use of platelet transfusion by the interprofessional team (1).
Platelets play an integral role in hemostasis by its response to vascular injury. The relevance of platelet component therapy was better understood in the 1950s and 1960s when severe and fatal hemorrhagic complications of chemotherapy in leukemia were studied
The collected blood units were randomly assigned to two groups:
- Non-filtered platelet concentrates (NF-PC group).
- leukocyte-depleted platelet concentrates (LD-PC group). P-selectin (CD62p) is a type of glycoprotein stored in the Weibel-Palade bodies of vascular endothelial cells and platelet α-granules. Activated CD62P is a transmembrane protein expressed on the platelet surface. During platelet activation, the expression of CD62P on the surface of the cell membrane is dramatically increased in PCs without leukocyte depletion, due to the presence of WBCs and cytokines ,and is accompanied by an increase in the expression level of plasma soluble CD62
- Conditions
- Platelet Storage Lesion(PSL)
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 |
|---|---|---|
| Non-filtered platelet concentrates (NF-PC group). | In NF-PC group, 90 whole blood units were collected with Tripple blood bags, Six NF-PCs were pooled together and stored in a horizonal shaker at 20 ± 2C for 5 days . | |
| leukocyte-depleted platelet concentrates (LD-PC group). | In LD-PC group, another 90 whole blood units were collected using Whole Blood Filter Saving Platelets (WB-SP) bags with an integrated leukoreduction filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess platelet activation .
assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .
Measured: baseline
Secondary outcomes (1)
CD62p assessment .
CD62p assessment of platelet storage lesion(PSL)in platelet concentrates .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Platelet Storage Lesion(PSL)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna Mamdoh Ayad Benyamen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144074
- Sponsor's protocol ID
- platelet storage lesion
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Freireich EJ. Origins of platelet transfusion therapy. Transfus Med Rev. 2011 Jul;25(3):252-6. doi: 10.1016/j.tmrv.2011.01.003. Epub 2011 Mar 2.
PubMed 21371858Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.
PubMed 16322778Solves Alcaina P. Platelet Transfusion: And Update on Challenges and Outcomes. J Blood Med. 2020 Jan 24;11:19-26. doi: 10.2147/JBM.S234374. eCollection 2020.
PubMed 32158298Cines DB, Levine LD. Thrombocytopenia in pregnancy. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):144-151. doi: 10.1182/asheducation-2017.1.144.
PubMed 29222249
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD62P(P-selectin) as a Marker of Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates
- ClinicalTrials.gov ID
- NCT05144074
- Acronym / sponsor ID
- platelet storage lesion
- Conditions
- Platelet Storage Lesion(PSL)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 3 Dec 2021 (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.
The aim of this study to assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .
Detailed description
Platelet transfusion is a lifesaving procedure that is carried out to prevent bleeding or stop ongoing bleeding in patients with low platelet count or functional platelet disorders. There are minimum thresholds at which platelets are transfused in these patients, as not all low levels of platelet warrants a transfusion. Platelet is a scarce resource as processing, preparing, and transfusing it requires a great deal of precision and effort to maintain a certain quality. This activity highlights the use of platelet transfusion by the interprofessional team (1).
Platelets play an integral role in hemostasis by its response to vascular injury. The relevance of platelet component therapy was better understood in the 1950s and 1960s when severe and fatal hemorrhagic complications of chemotherapy in leukemia were studied
The collected blood units were randomly assigned to two groups:
- Non-filtered platelet concentrates (NF-PC group).
- leukocyte-depleted platelet concentrates (LD-PC group). P-selectin (CD62p) is a type of glycoprotein stored in the Weibel-Palade bodies of vascular endothelial cells and platelet α-granules. Activated CD62P is a transmembrane protein expressed on the platelet surface. During platelet activation, the expression of CD62P on the surface of the cell membrane is dramatically increased in PCs without leukocyte depletion, due to the presence of WBCs and cytokines ,and is accompanied by an increase in the expression level of plasma soluble CD62
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-filtered platelet concentrates (NF-PC group). | – | –In NF-PC group, 90 whole blood units were collected with Tripple blood bags, Six NF-PCs were pooled together and stored in a horizonal shaker at 20 ± 2C for 5 days . |
| leukocyte-depleted platelet concentrates (LD-PC group). | – | –In LD-PC group, another 90 whole blood units were collected using Whole Blood Filter Saving Platelets (WB-SP) bags with an integrated leukoreduction filter |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All gender fullfilling inclusion criteria are participating in this study ,
Key inclusion criteria (5 listed)
- Donors who met criteria of Egyptian National Transfusion services
- Donors who had not taken any antiplatelet drugs for two weeks prior to donation
- pre-collection platelet count ≥200×109 /L.
- Blood grouping.
- Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).
Key exclusion criteria (4 listed)
- Donors who not met criteria of Egyptian National Transfusion services
- Donors who had taken any antiplatelet drugs for two weeks prior to donation
- pre-collection platelet count <200×109 /L.
- Reactive serology
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
assess platelet activation .
Time frame: baseline
assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .
1 secondary outcome
CD62p assessment .
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Background: PubMed 21371858Freireich EJ. Origins of platelet transfusion therapy. Transfus Med Rev. 2011 Jul;25(3):252-6. doi: 10.1016/j.tmrv.2011.01.003. Epub 2011 Mar 2.
- Background: PubMed 16322778Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.
- Background: PubMed 32158298Solves Alcaina P. Platelet Transfusion: And Update on Challenges and Outcomes. J Blood Med. 2020 Jan 24;11:19-26. doi: 10.2147/JBM.S234374. eCollection 2020.
- Background: PubMed 29222249Cines DB, Levine LD. Thrombocytopenia in pregnancy. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):144-151. doi: 10.1182/asheducation-2017.1.144.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Storage Lesion(PSL), run by Assiut University.
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 5 inclusion and 4 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Merna M. Ayad, resident (01284539330, Mernamamdoh150@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess platelet activation . (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05144074, which also lists 4 linked publications.
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 3 Dec 2021.