Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.
Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intercept Platelets | Experimental | Study patients receiving platelets that have been processed with the INTERCEPT pathogen inactivation system |
|
| Conventional Platelets | Active Comparator | Study patients receiving platelets processed by standard method without the INTERCEPT pathogen inactivation system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion of Pathogen Inactivated Platelets stored for 6-7 days | Device | pathogen inactivation of platelets for transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 hour corrected count increment for platelets | 1-h CCI | One hour after platelet transfusion |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion related adverse events | 24 hours after transfusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Larry Corash, M.D. | Cerus Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNBTS National Science Laboratory, Edinburgh and Western General Hospital | Edinburgh | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|