Mirasol-Treated Platelets - (Pathogen Reduction Extended Storage Study) (PRESS)

This study has been terminated.
(Part 1 completed, part 2 not done due to slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT01368211
First received: June 6, 2011
Last updated: February 27, 2014
Last verified: February 2014
  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 2-4 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.


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:
  • Change in Maximum Amplitude at 1-hour Post-transfusion [ Time Frame: 1-hour post transfusion ] [ Designated as safety issue: No ]
    Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion


Secondary Outcome Measures:
  • Change in Maximum Amplitude at 24-hours Post-transfusion [ Time Frame: 24 hour post transufusion ] [ Designated as safety issue: No ]
    Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion


Enrollment: 16
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (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 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).
Biological: Mirasol-treated Platelets

Mirasol-treated platelet units with:

  • Platelet yield between 2.4x10e11 and 4.5x10e11
  • Plasma carryover of >32%
  • Cell count > 800x103/µL
Other Names:
  • Mirasol
  • Pathogen Reduction
  • PRT
Active Comparator: Crossover Group 2
This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).
Biological: Mirasol-treated Platelets

Mirasol-treated platelet units with:

  • Platelet yield between 2.4x10e11 and 4.5x10e11
  • Plasma carryover of >32%
  • Cell count > 800x103/µL
Other Names:
  • Mirasol
  • Pathogen Reduction
  • PRT

Detailed Description:
  1. 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
  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.
  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.

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 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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368211

Locations
Denmark
Hematology Service Rigshospitalet
Copenhagen, Blegdamsvej, Denmark, 2100
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

Publications:
Responsible Party: Terumo BCTbio
ClinicalTrials.gov Identifier: NCT01368211     History of Changes
Other Study ID Numbers: CTS-0063
Study First Received: June 6, 2011
Results First Received: February 27, 2014
Last Updated: February 27, 2014
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 October 29, 2014