Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study) (PRESS)
This study is currently recruiting participants.
Verified June 2011 by Terumo BCTbio
Sponsor:
Terumo BCTbio
Information provided by:
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT01368211
First received: June 6, 2011
Last updated: June 24, 2011
Last verified: June 2011
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Purpose
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 2-3 days and for 7-days in PAS and 2) the correlation between the TEG® parameters and platelet count increments after platelet transfusions in thrombocytopenic subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombocytopenia |
Biological: Mirasol-treated Platelets |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by Terumo BCTbio:
Primary Outcome Measures:
- Thromboelastography (TEG) Parameters [ Time Frame: 1-hour post transfusion ] [ Designated as safety issue: No ]
The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-3 days and stored for 7 days:
- 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
Secondary Outcome Measures:
- TEG parameters vs. CCI [ Time Frame: 1 hour post transufusion ] [ Designated as safety issue: No ]2. 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Crossover Group 1
This study arm will receive first a Mirasol treated 2-3-day-old platelet transfusion and then a reference 2-3-day-old platelet transfusion (Mirasol-Reference sequence).
|
Biological: Mirasol-treated Platelets
Mirasol-treated platelet units with:
Other Names:
|
|
Active Comparator: Crossover Group 2
This study arm will receive first a reference untreated 2-3-day-old platelet transfusion and then a Mirasol treated 2-3-day-old platelet transfusion (Reference-Mirasol sequence).
|
Biological: Mirasol-treated Platelets
Mirasol-treated platelet units with:
Other Names:
|
Detailed Description:
To evaluate in thrombocytopenic subjects the efficacy and safety of platelets treated with Mirasol PRT in Platelet Additive Solution. The following safety and efficacy measures will be compared between Mirasol treated and untreated platelets stored for 2-3 days and stored for 7 days:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
- Have received (a) platelet transfusion(s) within the 7 days prior to randomization and the last platelet transfusion prior to randomization resulted in a platelet count increment > 10.000 .109/ml.
Exclusion Criteria:
- History of any hypersensitivity reaction to riboflavin or metabolites.
- History of refractoriness to platelet transfusions (defined as 2 successive CCI1hr<5000) or presence of 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368211
Locations
| Denmark | |
| Hematology Service Rigshospitalet | Recruiting |
| Copenhagen, Blegdamsvej, Denmark, 2100 | |
| Contact: Lene Udby, MD +45 3545 8894 | |
| Principal Investigator: Lene Udby, MD | |
Sponsors and Collaborators
Terumo BCTbio
Investigators
| Principal Investigator: | Pär Johansson, MD | Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark |
| Principal Investigator: | Lene Udby, MD | Hematology Service Rigshospitalet, Copenhagen Denmark |
More Information
No publications provided
| Responsible Party: | David Cox, Ph.D. / Director of Regulatory and Clinical Affairs, CaridianBCT Biotechnologies |
| ClinicalTrials.gov Identifier: | NCT01368211 History of Changes |
| Other Study ID Numbers: | CTS-0063 |
| Study First Received: | June 6, 2011 |
| Last Updated: | June 24, 2011 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Terumo BCTbio:
|
Mirasol Thrombocytopenic Pathogen reduction Platelets |
Thromboelastography CCI Corrected Count Increment |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013