Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival - Full Text View

Sponsors and Collaborators:	Navigant Biotechnologies Department of Defense
Information provided by:	Navigant Biotechnologies
ClinicalTrials.gov Identifier:	NCT00742001

Purpose

Feasibility trial to determine recovery and survival of RBCs from Mirasol-treated whole blood

Condition	Intervention	Phase
Healthy	Biological: Mirasol System for Whole Blood.	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Further study details as provided by Navigant Biotechnologies:

Primary Outcome Measures:

RBC recovery [ Time Frame: 24 hr post autologous infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

RBC survival [ Time Frame: 28 days post autologous infusion ] [ Designated as safety issue: No ]
SAE [ Time Frame: post autologous infusion of RBC ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Illumination dose #1	Biological: Mirasol System for Whole Blood. Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
2: Experimental Illumination dose #2	Biological: Mirasol System for Whole Blood. Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
3: Experimental Illumination dose #3	Biological: Mirasol System for Whole Blood. Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742001

Locations

United States, Ohio
University of Cincinnati, Hoxworth Blood Center	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Jose A Cancelas-Perez, MD 800-265-1515 cancelje@ucmail.uc.edu
Principal Investigator: Jose A Cancelas-Perez, MD

Sponsors and Collaborators

Navigant Biotechnologies

Department of Defense

More Information

Responsible Party:	Navigant Biotechnologies ( Director of Clinical Affairs )
Study ID Numbers:	CTS-0040
Study First Received:	August 25, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00742001
Health Authority:	United States: Food and Drug Administration

Keywords provided by Navigant Biotechnologies:

red blood cells
transfusion
recovery
feasibility
white blood cell inactivation

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009