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A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components (PIPER)

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ClinicalTrials.gov Identifier: NCT02549222
Recruitment Status : Enrolling by invitation
First Posted : September 15, 2015
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Cerus Corporation

Brief Summary:

This study is a prospective, non-randomized sequential cohort, open label, multi-center, non-inferiority, Phase IV surveillance study following transfusion of INTERCEPT PCs. The patient population will be hematology-oncology patients, including those undergoing hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions.

For each participating center, the study will start with a brief pilot run-in period with a group of at least 5 patients exposed only to conventional PCs. The purpose of this pilot run-in is to evaluate study logistics and data collection methods within each study center. Data from the pilot phase will be included in the data analysis for the treatment comparison.

After the pilot run-in period, the study will be conducted in two sequential patient cohorts: 1) the Control cohort during which study patients will receive only conventional PCs, and 2) the INTERCEPT cohort during which patients will receive only INTERCEPT PCs. Patient enrollment at each Center will be monitored to target similar numbers of patients into the Control and Test Cohorts within each center. Centers may enroll Control and Test patients in ratios that vary from 2:1 to 1:2 due to institutional requirements to move rapidly to full INTERCEPT implementation, or due to availability issues with either Test or Control components. Within each Center, patient enrollment will be stratified in four categories: (1) chemotherapy only; and by use of conditioning regimens for hematopoietic stem cell transplantation (HSCT) in (2) myeloablative conditioning, (3) non-myeloablative conditioning, and (4) reduced intensity using the Center for International Blood and Marrow Transplant Research (CIBMTR) criteria. Note time from last chemotherapy treatment to first study transfusion should be no more than 30 days. To ensure both Test and Control cohorts have a similar allocation ratio (±10% per category) among the conditioning regimen strata, enrollment caps will be set for the Test cohorts, hence no Test patients will be enrolled to a stratum once the cap for the given stratum is met. Eligible patients will be enrolled in open Test strata sequentially as long as there is sufficient Test PC inventory available. Enrollment may be delayed for the Test cohort if sufficient inventory of Test PCs is not available.


Condition or disease Intervention/treatment
Transfusion Related Acute Lung Injury Other: Standard of Care

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 2932 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components
Actual Study Start Date : December 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
Control Cohort
During the Control cohort period patients will have study data collected following transfusion with only conventional PCs for up to 21 days of transfusion support, as clinically indicated in a manner that is consistent with the local standard of care.
Other: Standard of Care
INTERCEPT Cohort
During the INTERCEPT phase, patients will receive only INTERCEPT PCs and will have study data collected following transfusion for up to 21 days of transfusion support, as clinically indicated in a manner that is consistent with the local standard of care.
Other: Standard of Care



Primary Outcome Measures :
  1. Proportion of patients requiring treatment-emergent assisted mechanical ventilation during the study observation period. [ Time Frame: Up to 28 days ]
    For the purposes of this study, assisted mechanical ventilation defined as assisted ventilation started after the initiation of the first study PC and can be administered either by intubation or tight fitting mask with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP or BiPAP) ≥ 5 cm H2O, if PEEP or CPAP information is available. Assisted mechanical ventilation is selected as the primary outcome as it provides an objective measure of severe, clinically significant pulmonary injury. Patients will be assessed for the initiation of assisted ventilation within 7 days after each study PC transfusion.


Secondary Outcome Measures :
  1. Time from first study PC transfusion to onset of treatment-emergent assisted mechanical ventilation. [ Time Frame: Up to 28 days ]
    Time from first study Platelet Component transfusion to onset of treatment-emergent assisted mechanical ventilation.

  2. AEs occurring within 24 hours after the initiation of a study PC transfusion [ Time Frame: Up to 22 days ]
    Adverse Events occurring within 24 hours after the initiation of a study PC transfusion.

  3. TR occurring within 24 hours after the initiation of a study PC transfusion. [ Time Frame: Up to 22 days ]
    Transfusion Reactions occurring within 24 hours after the initiation of a study PC transfusion.

  4. SAEs occurring within 7 days after each study PC transfusion [ Time Frame: Up to 28 days ]
    Serious Adverse Events occurring within 7 days after each study PC transfusion

  5. ARDS occurring within 7 days after each study PC transfusion [ Time Frame: Up to 28 days ]
    Acute Respiratory Distress Syndrome occurring within 7 days after each study PC transfusion

  6. CSPAEs occurring within 7 days after each study PC transfusion [ Time Frame: Up to 28 days ]
    Clinically Serious Pulmonary Adverse Events occurring within 7 days after each study PC transfusion

  7. Mortality within 7 days after the last study PC transfusion, or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner (all deaths and deaths due to ARDS). [ Time Frame: Up to 28 days ]
    Mortality within 7 days after the last study PC transfusion, or until hospital discharge/discontinuation of outpatient platelet transfusion support, whichever is sooner (all deaths and deaths due to ARDS).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hematology-oncology disorders, including those undergoing hematopoietic stem cell transplant (HSCT), expected to require one or more PC transfusions will be included in the study.
Criteria

Inclusion Criteria:

  • Patients with a hematology-oncology disorder expected to require or requiring a transfusion of one or more PCs (time from last chemotherapy treatment to first study transfusion should be 30 days or less).
  • Written signed informed consent (unless exemption of individual consent is granted by the center's IRB).

Exclusion Criteria:

  • Assisted ventilation (administered by intubation or tight fitting mask with PEEP or CPAP ≥ 5 cm H2O) within 30 days prior to the first study PC transfusion. In the event that PEEP or CPAP values are unavailable for prior assisted ventilation events administered by intubation or tight fitting mask, they will be interpreted as meeting the exclusion criterion. For the purposes of this study, elective intubation of pediatric patients for the short-term protection of the airway during medical or surgical procedures does not qualify as assisted ventilation, provided that there is no parenchymal pulmonary lesion 24 hours after extubation.
  • Documented allergy to psoralens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549222


Locations
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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Stanford University
Palo Alto, California, United States, 94305
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel
Boston, Massachusetts, United States, 02215
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering
New York, New York, United States, 10065
Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
East Carolina University Hospital
Greenville, North Carolina, United States, 27834
United States, Ohio
TriHealth Cancer Institute
Cincinnati, Ohio, United States, 45220
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Cerus Corporation
Investigators
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Principal Investigator: Edward L Snyder, MD Yale New Haven Hospital

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Responsible Party: Cerus Corporation
ClinicalTrials.gov Identifier: NCT02549222     History of Changes
Other Study ID Numbers: CLI 00112
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Cerus Corporation:
pathogen reduction
INTERCEPT
platelet
pulmonary
ARDS
hematology
oncology
assisted ventilation
transfusion of platelet components
hematology-oncology patients
Additional relevant MeSH terms:
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Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Transfusion-Related Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Transfusion Reaction
Hematologic Diseases
Immune System Diseases