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Hemoglobin-Based Oxygen Carrier
PolyHeme for Hemorrhagic Shock
Phase 3
Waitlist Available
Research Sponsored by Northfield Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients following trauma who have sustained blood loss and are in shock
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test if giving injured patients PolyHeme, a type of artificial blood, will help them survive better than if they didn't receive it.
Who is the study for?
This trial is for adults who have experienced severe trauma with significant blood loss leading to shock. It's not suitable for those with fatal injuries, severe head trauma, pregnant women, individuals in cardiac arrest, or anyone refusing participation on personal grounds like religious beliefs.Check my eligibility
What is being tested?
The study tests the survival benefits of PolyHeme(R), a blood substitute given to severely injured patients in shock when real blood isn't available. Treatment starts before reaching the hospital and continues during the first 12 hours of hospital care.See study design
What are the potential side effects?
While specific side effects are not listed here, similar treatments may include allergic reactions, fever, or heart and lung complications. The safety profile will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have experienced significant blood loss and shock due to trauma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
Northfield LaboratoriesLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have experienced significant blood loss and shock due to trauma.I do not wish to participate in the trial due to personal reasons.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study have an age limit? If so, what is the maximum age of participants?
"This particular clinical trial is only for patients aged 18-0. In total, there are 141 trials for patients under the age of eighteen and 746 for senior citizens."
Answered by AI
Has this medication been cleared by the FDA?
"This medical intervention has received a safety score of 3. This is based on the fact that it is a Phase 3 trial, meaning there is some evidence of efficacy as well as multiple rounds of data affirming its safety."
Answered by AI
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