Clinical trial · Interventional
Italian Platelet Technology Assessment Study
A Multi-center, Single-blind, Randomized, Parallel, Non Inferiority Study to Separately Investigate the Effect of Standard Platelets Versus Platelets Prepared With Two Commercial Procedures of Pathogen Reduction Technologies (PRT) on Bleeding Incidence and Severity in Thrombocytopenic Recipients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patient enrolment below planned schedule
Summary
Brief summary (as posted)
Italian Platelet Technology Assessment Study (IPTAS) aims at comparing bleeding frequency and severity after transfusion of standard platelets versus platelets prepared with two commercial pathogen reduction technologies (PRT) and to perform a proteomic analysis of standard versus PRT platelets. The two technologies will be analyzed separately. Primary endpoint: incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets. Secondary endpoints: time to the first grade 2 or greater bleeding event after the first study transfusion; proportion of transfusions given to treat breakthrough bleeding; number of days with grade 2 or greater bleeding during the period of platelet transfusion support; number of platelet units transfused and total dose of platelets transfused per day of thrombocytopenic platelet support; proportion of patients with acute transfusion reactions; post-transfusion platelet count increments Observational endpoints: frequency of human leukocyte antigen (HLA) alloimmunization, frequency of clinical refractoriness to platelet transfusion with demonstrated HLA alloimmunization, frequency of clinical refractoriness to platelet transfusion that is persistent during the period of platelet support in the absence of HLA or human platelet antigen (HPA) alloimmunization Patients will be evaluated for 4 weeks after randomization.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Platelet transfusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pathogen reduced platelets
- description
- Transfusion
- interventionNames
- Procedure: Platelet transfusion
- type
- ACTIVE_COMPARATOR
- label
- Standard platelets
- description
- Transfusion
- interventionNames
- Procedure: Platelet transfusion
Primary outcomes (1)
- measure
- Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets
- timeFrame
- Within 4 weeks after randomization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. adults (\> 18 years) 2. a hematooncology diagnosis (includes patients newly diagnosed and previously diagnosed) 3. expected to require 2 or more PLT transfusions in 4 weeks 4. hospital admission (patients admitted to out-patient clinics will not be enrolled) 5. chemotherapy, related and matched unrelated donor (MUD)transplant recipients 6. recurrent auto-transplanted patients, requiring chemotherapy 7. negative pregnancy test in female patients less than 60 years old Exclusion Criteria: 1. presence of HLA class I abs on admission with PRA \>20% 2. historical documented record of 2 or more 1 hour post-TX PLT corrected count increments \<5,000 per microliter 3. previously included in IPTAS 4. diagnosis of a solid tumor
References
Publications (1)
- BACKGROUNDRebulla P, Grazzini G, Liumbruno GM, Aprili G, Formisano S, Girelli G, Marconi M, Salvaneschi L, Strada P, Zolla L. Pathogen inactivated platelets and prevention of immunological adverse reactions: the Italian Platelet Technology Assessment Study (IPTAS). Blood Transfus 2009;7 Suppl 1:s19-s21. DOI 10.2450/2009.0013-09.