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Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception From Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection [Polymerized Human Hemoglobin (Pyridoxylated), PolyHeme(R)] When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00076648
Enrollment
Unknown
Registered
2004-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2006-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhagic Shock

Brief summary

This study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

Interventions

DRUGPoly SFH-P Injection

Sponsors

Northfield Laboratories
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients following trauma who have sustained blood loss and are in shock

Exclusion criteria

* Patients who have sustained unsurvivable injuries * Patients who have severe head injury * Pregnant females * Patients found in cardiac arrest * Patients who object to participation (e.g., religious grounds, wearing exclusion bracelet).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026