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

Phase 2

• Conditions: Wounds and Injuries
• Interventions: Drug: Hemoglobin-based oxygen carrier-201 (HBOC 201); Other: Standard of Care

• Registration Number: NCT00301483
• Lead Sponsor: Biopure Corporation

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-13
• Status Verified: 2008-02
• Last Update Submitted: 2008-03-05
• Last Update Posted: 2008-03-06
• Primary Completion: 2008-09
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Hemoglobin-based oxygen carrier-201 (HBOC 201)	HBOC-201 followed by standard therapy
2	Standard of Care	Standard Therapy

Primary Outcome Measures

Name	Time	Method
Safety/Tolerability of HBOC-201 for treatment of hypoperfusion in trauma by analysis of AEs/SAEs attributed to study drug	Duration of the study (Randomization through 28-day follow-up)

Secondary Outcome Measures

Name	Time	Method
Efficacy/feasibility of the following measurements in trauma studies (list is not all inclusive): Time to serum lactate improvement, Base deficit (BD) improvement, BD > 5 over 24 hrs, 24 hr stability, Infection, Vent time	Duration of the study (Randomization through 28-day follow-up)

Trial Locations

Locations (1)

Department of Surgery: Johannesburg Hospital; 🇿🇦 Johannesburg, Gauteng, South Africa