Platelet StorageNCT03280823
Effect of Platelet Storage on Complement Activation
An observational study of Platelet Storage, run by Shimaa Abdeleem.
Trial summary
Platelet units are stored and complement factors are evaluated Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Platelet Storage
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to Dec 2018
- 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 45 years
- All sexes
- Adult
Study population: No Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets. Negative screening and confirmatory tests will be done for all platelet donors
Who may be able to join
- Negative screening and confirmatory tests will be done for all platelet donors
Who cannot join
- Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.
Trial locations and contacts
No sites are listed yet.
About this study
Platelet units are stored and complement factors are evaluated
Read the detailed description
Ten units of platelets will be selected from the regular inventory of the Central Blood Transfusion Services/Assiut University Hospitals . All units of platelets will be collected, processed, and tested following the standard procedures.
Thesis units will be stored on a platelet rotator with the temperature controlled between 22 and 24c. Samples will be obtained using a sterile technique .
The investigators will take basal sample and samples on day 2,3,4 and 5. Complement components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal pathway).
This evaluation will be done using ELISA technique
- Conditions
- Platelet Storage
- Keywords
- complement system
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Dec 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Platelet StorageStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shimaa Abdeleem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shimaa Abdeleem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280823
- Sponsor's protocol ID
- platelets and complement
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.
PubMed 28671303
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet Storage on Complement Activation
- ClinicalTrials.gov ID
- NCT03280823
- Acronym / sponsor ID
- platelets and complement
- Conditions
- Platelet Storage
- Keywords
- complement system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shimaa AbdeleemUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Sep 2017 (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.
Platelet units are stored and complement factors are evaluated
Detailed description
Ten units of platelets will be selected from the regular inventory of the Central Blood Transfusion Services/Assiut University Hospitals . All units of platelets will be collected, processed, and tested following the standard procedures.
Thesis units will be stored on a platelet rotator with the temperature controlled between 22 and 24c. Samples will be obtained using a sterile technique .
The investigators will take basal sample and samples on day 2,3,4 and 5. Complement components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal pathway).
This evaluation will be done using ELISA technique
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- No Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets. Negative screening and confirmatory tests will be done for all platelet donors
Key inclusion criteria (1 listed)
- Negative screening and confirmatory tests will be done for all platelet donors
Key exclusion criteria (1 listed)
- Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.
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
Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Background: PubMed 28671303Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.
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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, run by Shimaa Abdeleem.
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 1 inclusion and 1 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 13 Sep 2017. 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 Shimaa A Ahmed (01065952778, shimaaabdeleem11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation. (time frame: 5 days). 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 NCT03280823, which also lists 1 linked publication.
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 13 Sep 2017.