Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components.

Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components (Capture). - Capture trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001035-20-DE

Enrollment

166

Registered

2015-07-27

Start date

2016-06-10

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia MedDRA version: 20.0 Level: HLT Classification code 10043555 Term: Thrombocytopenias System Organ Class: 100000004851

Interventions

Product Name: Theraflex UV-Platelets Pharmaceutical Form: Concentrate and solvent for solution for infusion Product Name: Untreated plasma reduced platelet concentrate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Haemato-oncological patients with thrombocytopenia or expected to become thrombocytopenic; - Expected to receive = 1PLT transfusions during their hospital stay; - Age = 18 years; - Written Informed Consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 116 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Known immunological refractoriness to PLT transfusions, i.e. HLA and/or HPA alloimmunization (documented in the patient’s medical record); - History or diagnosis of an autoimmune disease affecting haemostasis; - Acute or chronic Disseminated Intravascular Coagulation (DIC); - History or diagnosis of Thrombotic Thrombocytopenic Purpura or Haemolytic Uremic Syndrome; - Severe uncontrolled infection; - Positive serum or urine pregnancy test; - Lactation; - Simultaneous participation in another interventional Trial; - Previous inclusion in this trial; - Acute promyelocytic leukemia (AML, FAB subtype M3) - Active bleeding at time of enrolment requiring one or more RBC transfusions and/or therapeutic platelet transfusions; - Splenomegaly defined as a palpable spleen felt more than 4 cm below costal margin; - History of severe anaphylactic transfusion criteria; - Legal incapacity or other circumstances preventing the patient from understanding the nature, meaning and implications of the clinical Trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to demonstrate the non-inferiority of UVC-treated plasma reduced platelet concentrates (UVC-PCs) in comparison to untreated plasma reduced platelet concentrates (Control-PCs) stored for up to 5 days in adult patients with hematologic or oncologic diseases and thrombocytopenia based on the 1 hour CCI of not more than 30% below the control.; Secondary Objective: Secondary efficacy objective: - To compare the post- transfusion PLT recovery, measured by platelet count increments (24 hour CCI, 1 hour and 24 hour CI) between treatment Groups;* - To compare PLT and RBC transfusions support between treatment Groups;* Secondary safety objective: - Rate of bleeding = WHO grade 3 and grade 4;* - Rate of clinical refractoriness;* - Rate of immunologic refractoriness;* - Frequency of alloimmunization to neoantigens on PLTs; - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE). * assessed during Treatment period only, ** assessed during Treatment and follow-up periods ; Primary end point(s): The primary endpoint of the trial is to demonstrate the non-inferiority of UVC-PCs in comparison to untreated or gamma-irradiated platelet concentrates (control PCs) assessed by the 1-hour CCI calculated for each PLT transfusion on a maximum of 8 PLT transfusions, stored for up to 5 days, per patient during the treatment period. Definition of the non-inferiority value: Up to a 30% reduction in CCI (test Group vs. controll) will be considered as not inferior. ;Timepoint(s) of evaluation of this end point: On a maximum of 8 PLT transfusions per patient during the treatment period of max. 28 days	—

Measure

Time frame

Main Objective: The primary objective of the trial is to demonstrate the non-inferiority of UVC-treated plasma reduced platelet concentrates (UVC-PCs) in comparison to untreated plasma reduced platelet concentrates (Control-PCs) stored for up to 5 days in adult patients with hematologic or oncologic diseases and thrombocytopenia based on the 1 hour CCI of not more than 30% below the control.; Secondary Objective: Secondary efficacy objective: - To compare the post- transfusion PLT recovery, measured by platelet count increments (24 hour CCI, 1 hour and 24 hour CI) between treatment Groups;* - To compare PLT and RBC transfusions support between treatment Groups;* Secondary safety objective: - Rate of bleeding = WHO grade 3 and grade 4;* - Rate of clinical refractoriness;* - Rate of immunologic refractoriness;* - Frequency of alloimmunization to neoantigens on PLTs;** - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE).** * assessed during Treatment period only, ** assessed during Treatment and follow-up periods ; Primary end point(s): The primary endpoint of the trial is to demonstrate the non-inferiority of UVC-PCs in comparison to untreated or gamma-irradiated platelet concentrates (control PCs) assessed by the 1-hour CCI calculated for each PLT transfusion on a maximum of 8 PLT transfusions, stored for up to 5 days, per patient during the treatment period. Definition of the non-inferiority value: Up to a 30% reduction in CCI (test Group vs. controll) will be considered as not inferior. ;Timepoint(s) of evaluation of this end point: On a maximum of 8 PLT transfusions per patient during the treatment period of max. 28 days

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Secondary

Measure	Time frame
Secondary end point(s): - Mean 24-hour CCI, mean 1-hour CI and mean 24-hour CI calculated for each PLT transfusion on a maximum of 8 PLT transfusion;* - Mean number of PLT transfusion episodes and Units;* - Mean interval between PLT transfusions (days);* - Mean number of RBC transfusion episodes and Units;* - Rate of bleeding events = WHO grade 3 and grade 4;* - Rate of clinical refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5;* - Rate of immunologic refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5 and serologic conversion to positive tests for HLA-and/or HPA alloantibodies or antibodies to UVC-related neoantigens;* - Frequency of alloimmunization to neoantigens on PLTs - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE). * assessed during treatment period only; ** assessed during treatment and follow-up periods ;Timepoint(s) of evaluation of this end point: see remarks under E.5.2 secondary endpoints.	—

Measure

Time frame

Secondary end point(s): - Mean 24-hour CCI, mean 1-hour CI and mean 24-hour CI calculated for each PLT transfusion on a maximum of 8 PLT transfusion;* - Mean number of PLT transfusion episodes and Units;* - Mean interval between PLT transfusions (days);* - Mean number of RBC transfusion episodes and Units;* - Rate of bleeding events = WHO grade 3 and grade 4;* - Rate of clinical refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5;* - Rate of immunologic refractoriness defined as consecutive two consecutive transfusions with 1 hour CCI < 7.5 and serologic conversion to positive tests for HLA-and/or HPA alloantibodies or antibodies to UVC-related neoantigens;* - Frequency of alloimmunization to neoantigens on PLTs** - Rate of PLT transfusion-related adverse events (AEs) and serious adverse events (SAE).** * assessed during treatment period only; ** assessed during treatment and follow-up periods ;Timepoint(s) of evaluation of this end point: see remarks under E.5.2 secondary endpoints.

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Countries

Germany

Contacts

Public ContactHead R&D

DRK-Blutspendedienst NSTOB

Axel.Seltsam@bsd-nstob.de+495041772455

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026