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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

Thank you

Trial Information

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


When patient's platelet count, done in early morning every day, falls below
10000/microliter, physician in charge issues a platelet transfusion request to transfusion
service. Transfusion service (which knows patient treatment arm) issues a PRT product or a
standard product as indicated, typically within hours of request receipt; patient's
physician identifies unit code and intended recipient's code and determines vital signs
(pulse, blood pressure, body temp). Transfusion is started and completed in 30 min. Adverse
reactions are monitored by ward personnel and once a day IPTAS local coordinator visits the
ward, checks IPTAS patients' records, fills IPTAS forms, examines and interviews each
enrolled patient and transfers filled forms to data coordinating center in Milan.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Incidence of bleeding of grade 2 or greater in recipients of PRT platelets versus incidence in recipients of control (standard) platelets

Outcome Time Frame:

Within 4 weeks after randomization

Safety Issue:

Yes

Principal Investigator

Paolo Rebulla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Authority:

Italy: Ministry of Health

Study ID:

ISS-2007646931

NCT ID:

NCT01642563

Start Date:

October 2010

Completion Date:

August 2014

Related Keywords:

  • Leukemia
  • Lymphoma
  • Platelet transfusion
  • Leukemia
  • Transfusion transmissible infections
  • Chemotherapy
  • Allogeneic hemopoietic stem cell transplant
  • Leukemia
  • Lymphoma

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