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

Thrombocytopenia Clinical Trial

— PRESS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01368211
• Other study ID #: CTS-0063
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 6, 2011
• Last updated: February 27, 2014
• Start date: September 2010
• Est. completion date: May 2011

Study information

• Verified date: February 2014
• Source: Terumo BCTbio
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical 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 platelet count increments after platelet transfusions in thrombocytopenic subjects.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Thrombocytopenia
• Thrombocytosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Hematology Service Rigshospitalet	Copenhagen	Blegdamsvej

Sponsors (1)

Lead Sponsor	Collaborator
Terumo BCTbio

Country where clinical trial is conducted

Denmark, 

References & 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-hour post transfusion	No
Secondary	Change in Maximum Amplitude at 24-hours Post-transfusion	Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion	24 hour post transufusion	No