MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications

NCT07815431 | Not Yet Recruiting

• 1 other identifier: PRAMMIC-001
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate whether patients with Melanocortin-1 receptor (MC1R) mutations, associated with red hair, or having a red hair phenotype, have a higher incidence of anesthesia-related perioperative complications. Genomic data from patients that have undergone a surgical or medical procedure, requiring an anesthetic management are extracted from two cohorts - a Swedish (Merged Anaesthesia and Intensive Care Cohort in Sweden (MAICS)), and a British (UK Biobank UKBB)), and linked to relevant healthcare registries. The outcome variables studied are statistically adjusted for age, gender, timing of procedure during the study period, and socioeconomic factors.

Conditions

Anaesthesia Complication; Perioperative Adverse Events; Red Hair; Melanocortin 1 Receptor

Keywords

Red hair; Anesthesia; Surgery; Perioperative complications; Adverse events; Melanocortin 1 receptor mutation; MC1R

Outcome Measures

Primary Outcomes (1)

• Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.

  A composite of adverse events consisting of Death, Unplanned ICU-admission, Myocardial arrest (ICD10: I46), Myocardial infarction (ICD10: I21-22), Pneumonia (ICD10: J13-16, J18, J85, J86, A481), and Anaphylaxis (ICD10: T782, T805, T886) Up until 30 days after the procedure.

  Days 30 after a qualifying procedure.

Secondary Outcomes (2)

• Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.

  Days 30 after a qualifying procedure.

• Adverse events registered at the post anesthesia care unit (PACU)

  Hours 24 after a qualifying procedure.

Study Arms (3)

Exposure (high

Individuals from either MAICS or UKBB being homozygote/compound heterozygote for MC1R mutations, OR individuals from UKBB consistently reporting red hair phenotype.

Exposure (intermediate)

Individuals from either MAICS or UKBB being heterozygote for MC1R mutations, OR individuals from UKBB with diverse reporting of having red hair phenotype.

Non-exposure (control)

Individuals from either the MAICS or the UKBB databases carrying a MC1R wildtype, OR individuals from UKBB reporting a hair color other than red.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population consists of all available patients registered in either NPR/Sweden or HES/UKBB with a qualifying procedure code, and having been genotyped for a defined MC1R variant.

You may qualify if:

• A qualifying surgical procedure requiring specified anesthetic management.
• A qualifying medical procedure requiring specified anesthetic management.
• Caucasian origin.

You may not qualify if:

• None specified.

Sponsors & Collaborators

• Uppsala University: lead
• County Council of Gavleborg: collaborator
• Dalarna County Council, Sweden: collaborator

Study Sites (1)

Uppsala University, Department of Surgical Sciences

Uppsala, 75185, Sweden

Location

Central Study Contacts

Miklós Lipcsey, MD, PhD

CONTACT

0046 18 611 0000; miklos.lipcsey@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)