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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during first 30 minutes
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I need surgery for a burn covering 5-30% of my body.

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

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

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
~2050

Find a Location

Who is running the clinical trial?

University of ManitobaLead Sponsor
593 Previous Clinical Trials
199,364 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what medical conditions is Phenylephrine typically prescribed?

"Phenylephrine is typically prescribed to alleviate bronchial blockage. It can also provide relief from conditions like sinus congestion, allergic rhinitis, and ocular inflammation."

Answered by AI

Is it possible to enroll in this investigation at the present time?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this medical investigation, which was first posted on December 1st 2014, is seeking volunteers. This project requires 24 participants to be recruited from a single site."

Answered by AI

How many applicants are being granted admittance to this experiment?

"Affirmative. According to information held on clinicaltrials.gov, this research programme is still recruiting volunteers, having first been posted on December 1st 2014 and last edited November 1st 2022. 24 people are being sought from a single medical site."

Answered by AI

Are there any precedents for scientific research into Phenylephrine?

"Currently, 26 clinical trials are in progress to evaluate the effects of Phenylephrine. Of these studies, 5 have entered Phase 3. Moreover, 37 different sites across America are hosting experiments with this drug; a major contribution is being made by New Haven CT."

Answered by AI

Has Phenylephrine been confirmed by the FDA?

"The lack of clinical data regarding Phenylephrine's safety and efficacy resulted in it receiving a score of 1."

Answered by AI

Am I able to register for this research endeavor?

"Candidates seeking admission to this trial should have a history of blood loss, surgical intervention and be between 18 to 75 years old. This study is expecting around 24 participants in total."

Answered by AI

Are octogenarians permissible to participate in this clinical research?

"To be eligible for this trial, participants must range from 18 to 75 years of age. Alternatively, there are 59 studies available for minors and 308 investigations dedicated to individuals above the retirement age bracket."

Answered by AI
~3 spots leftby Jun 2025