NCT00742001

Brief Summary

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

September 10, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2008

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2008

Completed
10.7 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

August 25, 2008

Results QC Date

May 16, 2019

Last Update Submit

August 15, 2019

Conditions

Healthy

Keywords

red blood cellstransfusionrecoveryfeasibilitywhite blood cell inactivation

Outcome Measures

Primary Outcomes (1)

  • Red Blood Cell (RBC) Recovery

    The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.

    24-hour post autologous infusion of RBCs

Secondary Outcomes (2)

  • Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival

    28-days post autologous infusion of RBCs

  • Count of Participants With Serious Adverse Events (SAE)

    28-days post autologous infusion of RBCs

Study Arms (3)

Mirasol Illumination Dose #1

EXPERIMENTAL

Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs)

Biological: Mirasol System for Whole Blood.

Mirasol Illumination Dose #2

EXPERIMENTAL

Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs

Biological: Mirasol System for Whole Blood.

Mirasol Illumination Dose #3

EXPERIMENTAL

Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs

Biological: Mirasol System for Whole Blood.

Interventions

Mirasol System for Whole Blood.BIOLOGICAL

Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Also known as: Mirasol System, Mirasol
Mirasol Illumination Dose #1Mirasol Illumination Dose #2Mirasol Illumination Dose #3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
  • females incapable of becoming pregnant
  • males agreeing to use contraception during trial

You may not qualify if:

  • pregnancy or nursing
  • abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
  • major surgery
  • use of drugs affecting coagulation or RBC function
  • recent participation in other trials which may confound results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati, Hoxworth Blood Center

Cincinnati, Ohio, 45267, United States

Location

Limitations and Caveats

Two major limitations to the interpretation of these data. 1)the small sample size limited the interpretation of some of the data. 2)the high degree of inter-subject variability further limits the interpretation of potential trends seen in the data.

Results Point of Contact

Title
Marty Huntington / Sr Mgr Global Clinical Affairs
Organization
Terumo BCT
Marty.Huntington@terumobct.com
+1 (303) 231-4849

Study Officials

  • Jose Cancelas-Perez, M.D, Ph.D

    University of Cincinnati, Hoxworth Blood Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2008

First Posted

August 27, 2008

Study Start

September 10, 2008

Primary Completion

November 20, 2008

Study Completion

December 16, 2008

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-08

Locations

US(1)