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
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