NCT06697223Phase 2Completed

A Study to Assess Recovery and Survival of Radiolabeled Apheresis Platelet Components Treated With the INTERCEPT Blood System for Platelets With LED Illuminator.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-06-02Actual

Enrollment · participants40Actual

Source updated2026-08-04Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-07-09 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Post ~~infusion~~ ~~recovery~~ of Test ~~platelets~~ at ~~end of 5 day storage Measure: Post infusion survival of Test platelets at end~~ of 5 Day ~~storage~~

+ After

Measure: Post Infusion Recovery of Test Platelets at End of 5 Day Storage Measure: Post Infusion Survival of Test Platelets at End of 5 Day Storage

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Posted 2026-02-06 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~60 participants (planned)~~

+ After

40 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Oct 2025~~

+ After

2 Jun 2025

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Completed

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Study details

Conditions studied

Healthy Subjects

Treatments or interventions studied

Not recorded

Primary outcomes · main study measures

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measure: Post Infusion Recovery of Test Platelets at End of 5 Day Storage; description: Recovery of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.; timeFrame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets; measure: Post Infusion Survival of Test Platelets at End of 5 Day Storage; description: Survival of Test platelets stored for 5 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.; timeFrame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 5 days and fresh Control platelets

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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