ThrombocytopeniaNCT05038722
Function of Platelets Used for Transfusions
An observational study of Thrombocytopenia and Hematologic Malignancy, run by Sofia Ramström at 2 sites in Sweden.
Trial summary
Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, Hematologic Malignancy
- What is being tested?
- Platelet transfusion
- How many people
- 240 participants
- Where
- 2 sitesSweden
- Study dates
- 22 Nov 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants with malignant hematologic disorders undergoing cancer treatment at the Hematology ward.
Who may be able to join
- Participant undergoing treatment for malignant hematologic disorders
- Thrombocytopenia
- Require platelet transfusion
Who cannot join
- Participant requiring HLA-matched platelet transfusions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites
Region Östergötland
Linköping, 58185
Örebro University
Örebro, 70182
About this study
Official title: Flödescytometrisk utvärdering av Den Blodstillande förmågan Hos Trombocyter Avsedda för Transfusion
Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream.
We have developed a method with flow cytometry to measure platelet function markers. It allows us to determine which pathways that are initiated upon activation.
Read more
The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient.
The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.
Read the detailed description
Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream.
The role of platelets in hemostasis is complex. Upon vascular injury, platelets adhere at the injured site where they become activated, release their granule content and aggregate. Activation include changes in receptors, expression of activation markers and become procaoagulant. We have developed a method with flow cytometry to measures these platelet function markers. It allows us to determine which pathways that are initiated upon activation.
Platelets can be stored a maximum of 5-7 days before transfusion. However, the preparation process and subsequent storage can result in platelet lesions, affecting their ability to promote hemostasis and circulate after transfusion.
The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient.
The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.
We will be able to examine how this relates to platelet processing methods and storage duration.
Platelets will be transfused on normal indications to participants at the hematology ward. The platelet concentrates choosen to be transfused will be done according to regular routines at the blood center. We will thus not control what concentrates are transfused (i.e. preparation method and storage time) and hence included in the study.
A small sample will be taken from the platelet concentrate shortly before transfusion and platelet function analysed with the flow cytometry method. Transfusion response will be assessed in the participant by calculation of corrected count increment (CCI) which relates the increase in platelet concentration after transfusion to the number of platelets transfused and the blood volume. CCI is calculated at 1 and 24-hours after transfusion. Clincial variables that might affect the transfusion response such as infection and fever will be registered as well as bleeding. The number of days to next platelet transfusion will be followed up.
- Conditions
- Thrombocytopenia, Hematologic Malignancy
- Being tested
- Platelet transfusion
- Medical subject headings
- Thrombocytopenia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusionOther
Transfusion of platelet concentrates according to routine practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected count increment (CCI)
CCI relates the increase in platelet concentration in participants after transfusion to the number of platelets transfused and the participants blood volume.
Measured: 1- and 24 hours after transfusion.
Spontaneous and agonist induced expression of platelet activation markers on platelets in platelet concentrates.
Percentage of platelets expressing P-selectin, LAMP-1, phosphatidylserine and the active conformation of fibrinogen receptor.
Measured: Measured on the day of transfusion prior to transfusion.
Spontaneous and agonist induced formation of platelet subpopulations in platelet concentrates.
Percentage of normal sized platelets, small platelets and platelet fragments (microparticles).
Measured: Measured on the day of transfusion prior to transfusion.
Secondary outcomes (5)
Treatment of infection.
Use of antibiotics.
Measured: Prior to transfusion.
Signs of infection - fever.
Body temperature measurement.
Measured: Prior to transfusion.
Bleeding.
Signs of bleeding according to WHO-scale (0-4, where 4 is the worst outcome).
Measured: Prior to platelet transfusion and 24-hours after the transfusion.
Number of platelet transfusions
Total number of platelet transfusions a participant recieved before being incuded in the study (i.e before being transfused with the study specific platelet concentrate) in the treatment cycle.
Measured: From beginning of the cytotoxic treatment cycle to inclusion in the study, i.e receiving a study concentrate.
Days to next platelet transfusion.
The number of days until the next platelet transfusion occured after being transfused with the study specific platelet concentrate.
Measured: After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start22 Nov 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sofia Ramström
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sofia Ramström, Örebro University, Sweden
- Investigators
- Sofia Ramström, Ass. Prof, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038722
- Sponsor's protocol ID
- 2020-05968
- Status last verified
- Jul 2023
- First submitted
- 24 Aug 2021
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual results from flow cytometry analysis of platelet concentrates that underlie results in a publication after deidentification (text, tables and figures).
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flödescytometrisk utvärdering av Den Blodstillande förmågan Hos Trombocyter Avsedda för Transfusion
- ClinicalTrials.gov ID
- NCT05038722
- Acronym / sponsor ID
- 2020-05968
- Conditions
- Thrombocytopenia, Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sofia RamströmUniversity, hospital or other
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Sep 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.
Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream.
We have developed a method with flow cytometry to measure platelet function markers. It allows us to determine which pathways that are initiated upon activation.
The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient.
The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.
Detailed description
Cytotoxic treatment for malignant hematologic disorders often casue thrombocytopenia that can result in life threatening bleedings. This is prevented by platelet transfusions but these can cause serious transfusion reactions and thus the number of transused platelet concentrates should be limited. It is therefore important that the platelet concentrates contain functional platelets with long circulation time in the bloodstream.
The role of platelets in hemostasis is complex. Upon vascular injury, platelets adhere at the injured site where they become activated, release their granule content and aggregate. Activation include changes in receptors, expression of activation markers and become procaoagulant. We have developed a method with flow cytometry to measures these platelet function markers. It allows us to determine which pathways that are initiated upon activation.
Platelets can be stored a maximum of 5-7 days before transfusion. However, the preparation process and subsequent storage can result in platelet lesions, affecting their ability to promote hemostasis and circulate after transfusion.
The aim of this project is to assess to what degree spontaneous activation of platelets as well as their activation capacity affects the transfusion response (i.e. uptake in the circulation and circulation time) in the recipient.
The hypothesis is that transfusion of platelets with low spontaneous activation and high activation capacity will lead to a higher transfusion response in the recipient.
We will be able to examine how this relates to platelet processing methods and storage duration.
Platelets will be transfused on normal indications to participants at the hematology ward. The platelet concentrates choosen to be transfused will be done according to regular routines at the blood center. We will thus not control what concentrates are transfused (i.e. preparation method and storage time) and hence included in the study.
A small sample will be taken from the platelet concentrate shortly before transfusion and platelet function analysed with the flow cytometry method. Transfusion response will be assessed in the participant by calculation of corrected count increment (CCI) which relates the increase in platelet concentration after transfusion to the number of platelets transfused and the blood volume. CCI is calculated at 1 and 24-hours after transfusion. Clincial variables that might affect the transfusion response such as infection and fever will be registered as well as bleeding. The number of days to next platelet transfusion will be followed up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with malignant hematologic disorders undergoing cancer treatment at the Hematology ward.
Key inclusion criteria (3 listed)
- Participant undergoing treatment for malignant hematologic disorders
- Thrombocytopenia
- Require platelet transfusion
Key exclusion criteria (1 listed)
- Participant requiring HLA-matched platelet transfusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet transfusionTransfusion of platelet concentrates according to routine practice. | Other | – |
Primary outcome
Corrected count increment (CCI)
Time frame: 1- and 24 hours after transfusion.
CCI relates the increase in platelet concentration in participants after transfusion to the number of platelets transfused and the participants blood volume.
Spontaneous and agonist induced expression of platelet activation markers on platelets in platelet concentrates.
Time frame: Measured on the day of transfusion prior to transfusion.
Percentage of platelets expressing P-selectin, LAMP-1, phosphatidylserine and the active conformation of fibrinogen receptor.
Spontaneous and agonist induced formation of platelet subpopulations in platelet concentrates.
Time frame: Measured on the day of transfusion prior to transfusion.
Percentage of normal sized platelets, small platelets and platelet fragments (microparticles).
5 secondary outcomes
Treatment of infection.
Time frame: Prior to transfusion.
Signs of infection - fever.
Time frame: Prior to transfusion.
Bleeding.
Time frame: Prior to platelet transfusion and 24-hours after the transfusion.
Number of platelet transfusions
Time frame: From beginning of the cytotoxic treatment cycle to inclusion in the study, i.e receiving a study concentrate.
Days to next platelet transfusion.
Time frame: After the study platelet concentrate was transfused, followed for up to two weeks after transfusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: Yes. Individual results from flow cytometry analysis of platelet concentrates that underlie results in a publication after deidentification (text, tables and figures).
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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.
Sofia Ramström, Ass. Prof principal investigator
Örebro University, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Hematologic Malignancy, run by Sofia Ramström at 2 sites in Sweden.
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 3 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: enrolling by invitation, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected count increment (CCI) (time frame: 1- and 24 hours after transfusion.). The study lists 3 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 13 Jul 2023.