Blood Loss, SurgicalPhase 1NCT01731444
Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury
A Phase 1 study testing Phenylephrine in people with Blood Loss, Surgical, run by University of Manitoba at 1 site in Canada.
Trial summary
The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2014to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn injury requiring debridement and grafting between 5-30% TBSA
Who cannot join
- Head and neck, hand, foot, or genital burns
- On anticoagulants (except NSAIDs)
- On monoamine oxidase inhibitor or tricyclic antidepressant
- Coronary or peripheral vascular disease
- History of arrhythmias
- On a Beta-blocker
- History of vascular abnormality
- Hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3A 1R9
Justin P Gawaziuk, MSc, 2047873669, jgawaziuk@hsc.mb.ca
Sarvesh Logsetty, MD
About this study
Official title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.
The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.
Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.
- Conditions
- Blood Loss, Surgical
- Being tested
- Phenylephrine
- Keywords
- blood loss, burn, hemostasis
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | 20 ug/cc Receives: Drug: Phenylephrine |
| Epinephrine | Active comparator | 1:1000000 Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial blood pressure (MAP)
Mean arterial blood pressure
Measured: during first 30 minutes
Secondary outcomes (2)
Blood Pressure
Cut off for safety: Diastolic >140 or Systolic >180;
Recorded:
- just prior to induction of anesthesia
- maximum heart rate during time of procedure
- minimum heart rate during time of procedure
Measured: q15 min
Heart Rate
Recorded:
- just prior to induction of anesthesia
- maximum heart rate during time of procedure
- minimum heart rate during time of procedure
Measured: q15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study start1 Dec 2014
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731444
- Sponsor's protocol ID
- PhenylephrineRCT
- Status last verified
- May 2026
- First submitted
- 15 Nov 2012
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01731444
- Acronym / sponsor ID
- PhenylephrineRCT
- Conditions
- Blood Loss, Surgical
- Keywords
- blood loss, burn, hemostasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.
The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.
Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: Phenylephrine20 ug/cc |
| Epinephrine | Active comparator | Drug: Phenylephrine1:1000000 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Burn injury requiring debridement and grafting between 5-30% TBSA
Key exclusion criteria (8 listed)
- Head and neck, hand, foot, or genital burns
- On anticoagulants (except NSAIDs)
- On monoamine oxidase inhibitor or tricyclic antidepressant
- Coronary or peripheral vascular disease
- History of arrhythmias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine | Drug | Epinephrine, Phenylephrine |
Primary outcome
Mean arterial blood pressure (MAP)
Time frame: during first 30 minutes
Mean arterial blood pressure
2 secondary outcomes
Blood Pressure
Time frame: q15 min
Heart Rate
Time frame: q15 min
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phenylephrine in people with Blood Loss, Surgical, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Gawaziuk, MSc (2047873669, jgawaziuk@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean arterial blood pressure (MAP) (time frame: during first 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.