Trial Search Results
A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet Components
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.
Stanford is currently accepting patients for this trial.
- Other: Standard of Care
- 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).
- 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
Ages Eligible for Study
N/A - N/A
Genders Eligible for Study