A Single Site Safety and Tolerability Study of HBOC-201 in Trauma Subjects

Wounds and Injuries Clinical Trial

Official title: A Single-Center, Study to Evaluate the Safety and Tolerability of Hemoglobin-Based Oxygen Carrier-201 (HBOC 201) in Trauma Subjects. (Phase II - Safety and Tolerability)

Status Recruiting

Clinical Trial Summary

The main purpose of this study is to determine if HBOC-201 is safe and tolerable to trauma subjects, when given to treat the inadequate supply of blood and nutrients to tissues and organs.

Clinical Trial Description

This Phase II study will be a single-center, randomized, single-blind, parallel-group, standard therapy-controlled, variable dose study of HBOC 201 administered to trauma subjects with bleeding or potential for bleeding who require standard fluid therapy for treatment of hypoperfusion. The type and incidence of adverse events and serious adverse events attributed to the study drug will be analyzed.

Secondary variables in this safety and tolerability study, will be summarized with descriptive statistics and frequency tables. The purpose of this data collection is to assess efficacy variables and the feasibility of utilizing these parameters in future trauma studies that will assess parameters of morbidity and mortality and include, but are not limited to:

• Time to improvement of serum (or plasma) lactate

• Time to improvement in the Base Deficit

• Time to maintained stability (BD<5) over 24 hours

• Overall improvement in Base Deficit over 24 Hours

• Stability of subjects at 24 hours

• Time to meet treatment-stopping criteria

• Volume to meet treatment-stopping criteria

• Incidence of infectious complications (e.g., incidence of ventilator-associated pneumonia)

• Length of time on ventilator

• Incidence of multiple organ dysfunction (MOD)

Hemorrhage with subsequent hypoperfusion is a major cause of both immediate and delayed death in subjects who have sustained traumatic injuries. Effective therapies for hemorrhage to treat hypoperfusion that can be given immediately following injury are lacking. The following issues confound this problem further:

• Hemorrhaging trauma victims often have an immediate need for therapy to ensure adequate delivery of oxygen to vital tissues;

• Standard of care fluids such as Lactated Ringers Solution do not provide oxygen and blood can not be readily stored, transported or easily used in pre-hospital settings

• In the absence of oxygen-carrying fluid, traditional approaches to sustain vital organ perfusion, such as administration of intravenous fluid therapy, may have detrimental effects if given prior to hemostasis in certain subjects, particularly those with penetrating truncal injuries. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wounds and Injuries

• NCT number: NCT00301483
• Study type: Interventional
• Source: Biopure Corporation
• Contact: Tiana Gorham
• Email: tgorham@biopure.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2004
• Completion date: December 2008