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Vasoconstrictor

Phenylephrine for Blood Loss in Burn Surgery

Phase 1
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Burn injury requiring debridement and grafting between 5-30% TBSA
Be older than 18 years old
Must not have
Currently on a Beta-blocker
History of hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during first 30 minutes
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of epinephrine and phenylephrine solutions on blood loss during skin grafting in burn patients.

Who is the study for?
This trial is for individuals with burn injuries needing skin grafts covering 5-30% of their body, excluding burns on the head, neck, hands, feet, and genitals. Participants should not have heart or vascular diseases, arrhythmias, hypertension; nor be taking anticoagulants (except NSAIDs), monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers.
What is being tested?
The study tests if phenylephrine can control blood loss during skin grafting without affecting heart rate and blood pressure like epinephrine does. Patients will receive a phenylephrine solution injection at the injury site before grafting to see if it's more effective and safer than the standard epinephrine solution.
What are the potential side effects?
Phenylephrine may cause local reactions at the injection site. Systemic side effects are less expected but could include changes in blood pressure or heart rate; however, this study aims to demonstrate that these systemic effects are minimized compared to epinephrine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for a burn covering 5-30% of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking a Beta-blocker medication.
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I have a history of high blood pressure.
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I have burns on my head, neck, hands, feet, or genital areas.
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I am currently taking blood thinners.
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I am currently taking a monoamine oxidase inhibitor or tricyclic antidepressant.
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I have a history of heart or blood vessel disease.
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I have a history of irregular heartbeats.
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I have a history of blood vessel problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during first 30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and during first 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean arterial blood pressure (MAP)
Secondary study objectives
Blood Pressure
Heart Rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PhenylephrineExperimental Treatment1 Intervention
20 ug/cc
Group II: EpinephrineActive Control1 Intervention
1:1000000
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
2014
Completed Phase 4
~2040

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
619 Previous Clinical Trials
206,697 Total Patients Enrolled

Media Library

Phenylephrine (Vasoconstrictor) Clinical Trial Eligibility Overview. Trial Name: NCT01731444 — Phase 1
Blood Loss Research Study Groups: Phenylephrine, Epinephrine
Blood Loss Clinical Trial 2023: Phenylephrine Highlights & Side Effects. Trial Name: NCT01731444 — Phase 1
Phenylephrine (Vasoconstrictor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01731444 — Phase 1
~1 spots leftby Jun 2025
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