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

NCT01368211 | Terminated Phase 2 Results DMC

• 1 other identifier: CTS-0063
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopenia

Keywords

Mirasol; Thrombocytopenic; Pathogen reduction; Platelets; Thromboelastography; CCI; Corrected Count Increment

Outcome Measures

Primary Outcomes (1)

• 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

  pre-transfusion, 1-hour post transfusion

Secondary Outcomes (1)

• Change in Maximum Amplitude at 24-hours Post-transfusion

  pre-transfusion, 24-hour post transfusion

Study Arms (2)

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).

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).

Biological: 2-4-day-old Mirasol-treated Platelets Transfusion; Biological: 2-4-day-old Untreated Platelets Transfusion

Interventions

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

Also known as: Mirasol, Pathogen Reduction, PRT

Mirasol first, then Reference; Reference first, then Mirasol

2-4-day-old Untreated Platelets Transfusion 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

Mirasol first, then Reference; Reference first, then Mirasol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo BCTbio: lead

Study Sites (1)

Hematology Service Rigshospitalet

Copenhagen, Blegdamsvej, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 23278371 RESULT

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Limitations and Caveats

Small numbers of subjects

Results Point of Contact

• Title: Dr. Pär Johansson
• Organization: Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark

per.johansson@rh.regionh.dk

+45 35452030

Study Officials

• Pär Johansson, MD

  Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark

  PRINCIPAL INVESTIGATOR

• Lene Udby, MD

  Hematology Service Rigshospitalet, Copenhagen Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 28, 2016
• Results First Posted: April 7, 2014

Record last verified: 2016-05

Locations

DK (1)