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

NCT ID: NCT01368211

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-05-31

Brief 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 platelet count increments after platelet transfusions in thrombocytopenic subjects.

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.

Conditions

Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Mirasol first, then Reference

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).

Group Type: ACTIVE_COMPARATOR

2-4-day-old Mirasol-treated Platelets Transfusion

Intervention Type: BIOLOGICAL

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 Transfusion

Intervention Type: BIOLOGICAL

2-4-day-old Untreated Platelets Units with:

• Platelet yield between 2.4x10e11 and 4.5x10e11
• Plasma carryover of >32%
• Cell count > 800x103/µL

Reference first, then Mirasol

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).

Group Type: ACTIVE_COMPARATOR

2-4-day-old Mirasol-treated Platelets Transfusion

Intervention Type: BIOLOGICAL

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 Transfusion

Intervention Type: BIOLOGICAL

2-4-day-old Untreated Platelets Units with:

• Platelet yield between 2.4x10e11 and 4.5x10e11
• Plasma carryover of >32%
• Cell count > 800x103/µL

Interventions

2-4-day-old Mirasol-treated Platelets Transfusion

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

Intervention Type: BIOLOGICAL

2-4-day-old Untreated Platelets Transfusion

2-4-day-old Untreated Platelets Units with:

• Platelet yield between 2.4x10e11 and 4.5x10e11
• Plasma carryover of >32%
• Cell count > 800x103/µL

Intervention Type: BIOLOGICAL

Other Intervention Names

Mirasol; Pathogen Reduction; PRT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Terumo BCTbio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pär Johansson, MD

Role: PRINCIPAL_INVESTIGATOR

Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark

Lene Udby, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology Service Rigshospitalet, Copenhagen Denmark

Locations

Hematology Service Rigshospitalet

Copenhagen, Blegdamsvej, Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 23278371 (View on PubMed)

Other Identifiers

CTS-0063

Identifier Type: -

Identifier Source: org_study_id