---
title: Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
nct_id: NCT00261924
overall_status: COMPLETED
phase: PHASE3
sponsor: Cerus Corporation
study_type: INTERVENTIONAL
primary_condition: Thrombocytopenia
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00261924.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00261924"
ct_last_update_post_date: 2010-04-14
last_seen_at: "2026-05-12T06:57:15.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days

**Official Title:** Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection

**NCT ID:** [NCT00261924](https://clinicaltrials.gov/study/NCT00261924)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 211
- **Lead Sponsor:** Cerus Corporation
- **Conditions:** Thrombocytopenia
- **Start Date:** 2005-10
- **Completion Date:** 2009-07
- **CT.gov Last Update:** 2010-04-14

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* At least 16 years old
* Written informed consent
* Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
* Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia

Exclusion Criteria:

* Refractoriness to platelet transfusion
* Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
* Use of IL-11 (Neumega®) or other investigational platelet growth factor
* Disseminated intravascular coagulation (DIC)
* Clinically or radiologically detectable splenomegaly
* Previous participation in the study
```

## Arms

- **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

## Interventions

- **Transfusion of Pathogen Inactivated Platelets stored for 6-7 days** (DEVICE) — pathogen inactivation of platelets for transfusion

## Primary Outcomes

- **1 hour corrected count increment for platelets** _(time frame: One hour after platelet transfusion)_ — 1-h CCI

## Secondary Outcomes

- **Transfusion related adverse events** _(time frame: 24 hours after transfusion)_

## Locations (1)

- SNBTS National Science Laboratory, Edinburgh and Western General Hospital, Edinburgh, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.snbts national science laboratory, edinburgh and western general hospital|edinburgh||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00261924.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00261924*  
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