An assessment of the effects of pressors on graft blood flow after free tissue transfer surgery: A randomised study – Part II - Free 4 Flow (2)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015533-79-GB

Enrollment

Registered

2010-06-28

Start date

2010-02-08

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients in need of free flap facial reconstructive surgery

Interventions

Trade Name: Aramine Product Name: Metaraminol Pharmaceutical Form: Solution for infusion CAS Number: 33402-03-8 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Participant is willing and able to give informed consent for participation in the study. • Male or Female, aged 18 years or above. • Undergoing free flap surgery, with planned overnight ventilation on the Intensive Care Unit • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: The participant may not enter the study if ANY of the following apply: • Female participants who is pregnant, lactating • Patients withholding consent • Patients in whom pressor agents are contraindicated • Patients who weigh more than 100kg • Patients in whom overnight ventilation is not planned • Patients having repeat surgery within four weeks of the original procedure and trial participation

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine which pressor agent is most effective at maintaining systemic blood pressure whilst having negligible effect upon free tissue flow. ; Secondary Objective: To determine: 1. The relative change in flap perfusion after pressor infusion compared with "normal tissue." 2. Changes in flap flow after pressor infusion 3. Differences in frequency spectrum of skin blood flow between flaps and normal tissue before and after pressor infusion 4. Optimal drug concentration of the agents used to maintain systemic blood pressure and free flap flow. ;Primary end point(s): Absolute change in transfer function (flap vascular resistance) after pressor infusion	—

Measure

Time frame

Main Objective: To determine which pressor agent is most effective at maintaining systemic blood pressure whilst having negligible effect upon free tissue flow. ; Secondary Objective: To determine: 1. The relative change in flap perfusion after pressor infusion compared with "normal tissue." 2. Changes in flap flow after pressor infusion 3. Differences in frequency spectrum of skin blood flow between flaps and normal tissue before and after pressor infusion 4. Optimal drug concentration of the agents used to maintain systemic blood pressure and free flap flow. ;Primary end point(s): Absolute change in transfer function (flap vascular resistance) after pressor infusion

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026