ThrombocytopeniaPhase 2/3PRESSNCT01368211
Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study)
A Phase 2/3 study testing 2-4-day-old Mirasol-treated Platelets Transfusion and 2-4-day-old Untreated Platelets Transfusion in people with Thrombocytopenia, run by Terumo BCTbio at 1 site in Denmark.
Trial summary
The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- 2-4-day-old Mirasol-treated Platelets Transfusion and 2-4-day-old Untreated Platelets Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2010to May 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male or female of age of 18 years or older.
- Have thrombocytopenia or expected to develop thrombocytopenia requiring at least 3 platelet transfusions.
- Woman of child bearing potential must have a negative serum or urine pregnancy test within 72 hours before randomization.
- Subjects must have signed and dated the Informed Consent Form before performing any protocol related procedure.
Who cannot join
- History of any hypersensitivity reaction to riboflavin or metabolites.
- History of refractoriness to platelet transfusions (defined as 2 successive CCI1hr<5000) or presence of human leukocyte antigen (HLA) antibodies or positive lymphocytotoxicity or previously documented alloimmunization.
- Previous exposure to PRT-treated platelet concentrates.
- Active bleeding requiring one or more red cells concentrate transfusions (i.e. grade 3 or 4 bleeding according to the WHO bleeding assessment scale in Appendix 1).
- Exposure to an investigational product, within 30 days before randomization.
- Splenomegaly (presence of a palpable spleen whose border could be felt more than 4 cm below the costal margin) or splenectomy.
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- History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura (ITP), Thrombotic Thrombocytopenia Purpura (TTP), or Haemolytic Uremic Syndrome (HUS).
- Use of prohibited medication (see section 5.5).
- Pregnant or lactating females.
- Any medical condition or treatment that would be expected to compromise the effectiveness of a platelet transfusion or that would interfere with an expected platelet count increment.
- Any other medical condition that would compromise the participation of the subject in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRESS Pathogen Reduction Extended Storage Study PRESS (Pathogen Reduction Extended Storage Study) A Pilot Study of Mirasol Platelets Treated in Platelet Additive Solution in Thrombocytopenic Patients
The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.
Read the detailed description
- To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated with Mirasol Pathogen Reduction Technology (PRT) in Platelet Additive Solution. The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-4 days and stored for 7 days:
- Thrombelastography (TEG®) parameters: reaction time R, alpha angle α and maximal amplitude (MA)
- Platelet Count Increment and Corrected Count Increment
- Time to next platelet transfusion
- Incidence of transfusion related (serious) adverse events
- Incidence and severity of bleedings
- To evaluate the use of the TEG® parameters as a measure for platelet transfusion efficacy and to evaluate the correlation between the TEG® parameters and the platelet Corrected Count Increments after platelet transfusions in thrombocytopenic subjects.
- Conditions
- Thrombocytopenia
- Being tested
- 2-4-day-old Mirasol-treated Platelets Transfusion, 2-4-day-old Untreated Platelets Transfusion
- Keywords
- Mirasol, Thrombocytopenic, Pathogen reduction, Platelets, Thromboelastography, CCI, Corrected Count Increment
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-4-day-old Mirasol-treated Platelets TransfusionBiological
Also called Mirasol, Pathogen Reduction, PRT
2-4-day-old Mirasol-treated Platelets Units with:
- Platelet yield between 2.4x10e11 and 4.5x10e11
- Plasma carryover of >32%
- Cell count > 800x103/µL
2-4-day-old Untreated Platelets TransfusionBiological
2-4-day-old Untreated Platelets Units with:
- Platelet yield between 2.4x10e11 and 4.5x10e11
- Plasma carryover of >32%
- Cell count > 800x103/µL
| Study group | Role | What they receive |
|---|---|---|
| Mirasol first, then Reference | Active comparator | This study arm will receive first a 2-4-day-old Mirasol-treated platelets transfusion and then a reference 2-4-day-old untreated platelets transfusion (Mirasol-Reference sequence). Receives: Biological: 2-4-day-old Mirasol-treated Platelets Transfusion; Biological: 2-4-day-old Untreated Platelets Transfusion |
| Reference first, then Mirasol | Active comparator | This study arm will receive first a reference 2-4-day-old untreated platelets transfusion and then a 2-4-day-old Mirasol-treated platelets transfusion (Reference-Mirasol sequence). Receives: Biological: 2-4-day-old Mirasol-treated Platelets Transfusion; Biological: 2-4-day-old Untreated Platelets Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Amplitude at 1-hour Post-transfusion
Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion
Measured: pre-transfusion, 1-hour post transfusion
Secondary outcomes (1)
Change in Maximum Amplitude at 24-hours Post-transfusion
Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion
Measured: pre-transfusion, 24-hour post transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2011
- Study completionMay 2011
Why it stopped: Part 1 completed, part 2 not done due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Terumo BCTbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pär Johansson, MD, Principal investigator, Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen DenmarkLene Udby, MD, Principal investigator, Hematology Service Rigshospitalet, Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368211
- Sponsor's protocol ID
- CTS-0063
- Acronym
- PRESS
- Status last verified
- May 2016
- First submitted
- 6 Jun 2011
- Last updated
- 28 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Johansson PI, Simonsen AC, Brown PN, Ostrowski SR, Deberdt L, Van Hoydonck P, Yonemura SS, Goodrich RP. A pilot study to assess the hemostatic function of pathogen-reduced platelets in patients with thrombocytopenia. Transfusion. 2013 Sep;53(9):2043-52. doi: 10.1111/trf.12055. Epub 2012 Dec 24.
PubMed 23278371
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRESS Pathogen Reduction Extended Storage Study PRESS (Pathogen Reduction Extended Storage Study) A Pilot Study of Mirasol Platelets Treated in Platelet Additive Solution in Thrombocytopenic Patients
- ClinicalTrials.gov ID
- NCT01368211
- Acronym / sponsor ID
- PRESS / CTS-0063
- Conditions
- Thrombocytopenia
- Keywords
- Mirasol, Thrombocytopenic, Pathogen reduction, Platelets, Thromboelastography, CCI, Corrected Count Increment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part 1 completed, part 2 not done due to slow enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Terumo BCTbioIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Posted 7 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PRESS trial is a single-center, two-part, randomized cross-over pilot study in Copenhagen that will evaluate 1) the safety and performance of Mirasol-treated and untreated platelet products stored for 2-4 days and for 7-days in Platelet Additive Solution (PAS) and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.
Detailed description
- To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated with Mirasol Pathogen Reduction Technology (PRT) in Platelet Additive Solution. The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-4 days and stored for 7 days:
- Thrombelastography (TEG®) parameters: reaction time R, alpha angle α and maximal amplitude (MA)
- Platelet Count Increment and Corrected Count Increment
- Time to next platelet transfusion
- Incidence of transfusion related (serious) adverse events
- Incidence and severity of bleedings
- To evaluate the use of the TEG® parameters as a measure for platelet transfusion efficacy and to evaluate the correlation between the TEG® parameters and the platelet Corrected Count Increments after platelet transfusions in thrombocytopenic subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirasol first, then Reference | Active comparator | Biological: 2-4-day-old Mirasol-treated Platelets Transfusion, Biological: 2-4-day-old Untreated Platelets TransfusionThis study arm will receive first a 2-4-day-old Mirasol-treated platelets transfusion and then a reference 2-4-day-old untreated platelets transfusion (Mirasol-Reference sequence). |
| Reference first, then Mirasol | Active comparator | Biological: 2-4-day-old Mirasol-treated Platelets Transfusion, Biological: 2-4-day-old Untreated Platelets TransfusionThis study arm will receive first a reference 2-4-day-old untreated platelets transfusion and then a 2-4-day-old Mirasol-treated platelets transfusion (Reference-Mirasol sequence). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of age of 18 years or older.
- Have thrombocytopenia or expected to develop thrombocytopenia requiring at least 3 platelet transfusions.
- Woman of child bearing potential must have a negative serum or urine pregnancy test within 72 hours before randomization.
- Subjects must have signed and dated the Informed Consent Form before performing any protocol related procedure.
Key exclusion criteria (11 listed)
- History of any hypersensitivity reaction to riboflavin or metabolites.
- History of refractoriness to platelet transfusions (defined as 2 successive CCI1hr<5000) or presence of human leukocyte antigen (HLA) antibodies or positive lymphocytotoxicity or previously documented alloimmunization.
- Previous exposure to PRT-treated platelet concentrates.
- Active bleeding requiring one or more red cells concentrate transfusions (i.e. grade 3 or 4 bleeding according to the WHO bleeding assessment scale in Appendix 1).
- Exposure to an investigational product, within 30 days before randomization.
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 |
|---|---|---|
| 2-4-day-old Mirasol-treated Platelets TransfusionAlso: Mirasol, Pathogen Reduction, PRT2-4-day-old Mirasol-treated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of >32% * Cell count > 800x103/µL | Biological | Mirasol first, then Reference, Reference first, then Mirasol |
| 2-4-day-old Untreated Platelets Transfusion2-4-day-old Untreated Platelets Units with: * Platelet yield between 2.4x10e11 and 4.5x10e11 * Plasma carryover of >32% * Cell count > 800x103/µL | Biological | Mirasol first, then Reference, Reference first, then Mirasol |
Primary outcome
Change in Maximum Amplitude at 1-hour Post-transfusion
Time frame: pre-transfusion, 1-hour post transfusion
Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion
1 secondary outcome
Change in Maximum Amplitude at 24-hours Post-transfusion
Time frame: pre-transfusion, 24-hour post transfusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23278371Johansson PI, Simonsen AC, Brown PN, Ostrowski SR, Deberdt L, Van Hoydonck P, Yonemura SS, Goodrich RP. A pilot study to assess the hemostatic function of pathogen-reduced platelets in patients with thrombocytopenia. Transfusion. 2013 Sep;53(9):2043-52. doi: 10.1111/trf.12055. Epub 2012 Dec 24.
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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.
Pär Johansson, MD principal investigator
Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark
Lene Udby, MD principal investigator
Hematology Service Rigshospitalet, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2-4-day-old Mirasol-treated Platelets Transfusion and 2-4-day-old Untreated Platelets Transfusion in people with Thrombocytopenia, run by Terumo BCTbio at 1 site in Denmark.
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 11 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: stopped early, as of the sponsor's last update on 28 Jun 2016. 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 Denmark. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Maximum Amplitude at 1-hour Post-transfusion (time frame: pre-transfusion, 1-hour post transfusion). 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 NCT01368211, 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 28 Jun 2016.