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

Primary Purpose

Thrombocytopenia

Status

Terminated

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

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

2-4-day-old Untreated Platelets Transfusion

About this trial

This is an interventional basic science trial for Thrombocytopenia focused on measuring Mirasol, Thrombocytopenic, Pathogen reduction, Platelets, Thromboelastography, CCI, Corrected Count Increment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hematology Service Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Mirasol first, then Reference

Reference first, then Mirasol

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Maximum Amplitude at 24-hours Post-transfusion

Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion

Full Information

NCT ID

NCT01368211

First Posted

June 6, 2011

Last Updated

May 23, 2016

Sponsor

Terumo BCTbio

1. Study Identification

Unique Protocol Identification Number

NCT01368211

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Terminated

Why Stopped

Part 1 completed, part 2 not done due to slow enrollment

Study Start Date

September 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Terumo BCTbio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombocytopenia

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mirasol first, then Reference

Arm Type

Active Comparator

Arm Description

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).

Arm Title

Reference first, then Mirasol

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Biological

Intervention Name(s)

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

Other Intervention Name(s)

Mirasol, Pathogen Reduction, PRT

Intervention Description

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

Intervention Name(s)

2-4-day-old Untreated Platelets Transfusion

Intervention Description

2-4-day-old Untreated Platelets Units with: Platelet yield between 2.4x10e11 and 4.5x10e11 Plasma carryover of >32% Cell count > 800x103/µL

Primary Outcome Measure Information:

Title

Change in Maximum Amplitude at 1-hour Post-transfusion

Description

Thromboelastography (TEG) Parameter: Pre- to post-transfusional modification of Maximum Amplitude at 1-hour post-transfusion

Time Frame

pre-transfusion, 1-hour post transfusion

Secondary Outcome Measure Information:

Title

Change in Maximum Amplitude at 24-hours Post-transfusion

Description

Thromboelastography parameter: Pre- to post-transfusional modification in Maximum Amplitude at 24-hours post-transfusion

Time Frame

pre-transfusion, 24-hour post transfusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pär Johansson, MD

Organizational Affiliation

Transfusion Service Rigshospitalet - Dept of Immunology, Copenhagen Denmark

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lene Udby, MD

Organizational Affiliation

Hematology Service Rigshospitalet, Copenhagen Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hematology Service Rigshospitalet

City

Copenhagen

State/Province

Blegdamsvej

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

23278371

Citation

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.

Results Reference

result

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

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