Status:
COMPLETED
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Lead Sponsor:
Cerus Corporation
Collaborating Sponsors:
American National Red Cross
Conditions:
Chikungunya Virus
Dengue Virus
Eligibility:
All Genders
Brief Summary
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to ...
Detailed Description
Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consis...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
- Patient population as defined by each Investigator and their institutional review board (IRB).
- Patient provides written informed consent
- Exclusion Criteria
- Documented allergy to psoralens
- Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
- Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).
Exclusion
Key Trial Info
Start Date :
March 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT02305732
Start Date
March 1 2015
End Date
May 1 2016
Last Update
October 30 2018
Active Locations (8)
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1
Hospital General Menonita de Aibonito
Aibonito, Puerto Rico, 00705
2
Hospital General Menonita de Caguas
Caguas, Puerto Rico, 00725
3
Hospital General Menonita de Cayey
Cayey, Puerto Rico
4
Center Hospital Manati
Manatí, Puerto Rico, 00674