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Recovery and Lifespan of Red Blood Cells From Pathogen-reduced, Stored Blood Units

NCT03384407 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-01-09

No results posted yet for this study

Summary

The pilot study has two objectives: 1) to assess the post-infusion viability of INTERCEPT RBC by measuring the 24 hour post-infusion recovery ("PTR24") and lifespan of autologous RBCs prepared with the INTERCEPT System for RBC after storage for 35 days under standard blood banking conditions using two different RBC labels; 51-chromium and biotin. The control will be conventional untreated RBCs stored for 35 days; and 2) comparison and contrast of PTR24 and lifespan results of the 51-chromium and biotin labeling methods of RBC stored for 35 days under standard blood banking conditions. The purpose of gathering these data is to obtain more meaningful survival data for stored conventional and INTERCEPT RBCs over the entire 120 d RBC lifespan (51-Cr labeled RBC permits a maximum 28 d assessment as a result of 51-Cr's variable, progressive elution from RBC and radioactive half-life).

Conditions

  • Red Cell Survival in Healthy Volunteers

Interventions

DEVICE

Red cell survival in INTERCEPT treated red cells

Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03384407 on ClinicalTrials.gov