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.

Lead Sponsor:

Cerus Corporation

Stanford Investigator(s):

Intervention(s):

  • Other: Standard of Care

Eligibility


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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Marcellus
650-723-0567
Recruiting