Nordic Frostbite study

Prospective Randomised Non-inferiority Nordic Frostbite Treatment Study comparing tPA and iloprost therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000712-15-FI

Enrollment

Registered

2018-09-10

Start date

2018-12-17

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

frostbite

Interventions

Trade Name: Ilomedin Product Name: Ilomedin Product Code: B01 AC11 Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Actilyse Product Name: Actilyse Product Code: B01AD02 Pharmac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All severe cases of upper or lower extremity frostbite injury. A severe case is defined by involvement of one or more digits with clinical signs of ischaemia at or proximal to the proximal interphalangeal joint in the digits or interphalangeal joint in the thumb. Patients with multiple digit involvement but more distal ischaemia will also be included. All patients presenting within 48 hours from exposure and with no contraindications to either actilyse or iloprost therapy will be considered for inclusion. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Patients with non-severe frostbite or with contraindications to actilyse and / or iloprost therapy. Presentation > 48 hours from injury

Design outcomes

Primary

Measure	Time frame
Main Objective: Although both actilyse and iloprost apper to be beneficial in the treatment of frostbite, to date there have been no randomised studies directly comparing these two treatment modalities. Furthermore, due to a superior safety profile of iloprost over actilyse as well as easier logistics, there is a need to determine whether or not iloprost is at least as effective as actilyse in the treatment of frostbite in a non-inferiority trial.;Secondary Objective: Not Applicable;Primary end point(s): Initial survival or non-survival of distal extremity at risk. Length of hospital stay. Rate and level of amputation. Long-term assessment of quality of life;Timepoint(s) of evaluation of this end point: End of hospital stay and digit/extremity assessment when all wounds healed. 1 year long-term assessment of quality of life.	—

Measure

Time frame

Main Objective: Although both actilyse and iloprost apper to be beneficial in the treatment of frostbite, to date there have been no randomised studies directly comparing these two treatment modalities. Furthermore, due to a superior safety profile of iloprost over actilyse as well as easier logistics, there is a need to determine whether or not iloprost is at least as effective as actilyse in the treatment of frostbite in a non-inferiority trial.;Secondary Objective: Not Applicable;Primary end point(s): Initial survival or non-survival of distal extremity at risk. Length of hospital stay. Rate and level of amputation. Long-term assessment of quality of life;Timepoint(s) of evaluation of this end point: End of hospital stay and digit/extremity assessment when all wounds healed. 1 year long-term assessment of quality of life.

—

Countries

Finland

Contacts

Public ContactAndrew Lindford

Andrew Lindford

andrew.lindford@hus.fi+358504279661

Outcome results

None listed

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