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MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications (MARPAC)

10 september 2026 uppdaterad av: Uppsala University

The Presence of Red Hair Associated MC1R Mutations and the Incidence of Perioperative Anesthesia Complications: A Cohort Study

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

Background Perioperative complications may be associated with both suffering for the affected individuals, and a high cost for society. Available means for identifying individuals at risk should be considered.

Objective To investigate whether patients with MC1R variants (Asp84Glu, Arg142His Arg151Cys, Tyr152Ochre, Ile155Thr, Arg160Trp, Arg213Trp, Asp294His, or Arg306His) associated with red hair, or having a red hair phenotype have an increased incidence of anesthesia related perioperative complications.

Method This is a retrospective registry-based study including patients from one Swedish cohort (MAICS), and one British cohort (UKBB). MAICS is aggregation of four different cohorts; PronMed, Epihealth, Simpler, and the Swedish Twin Registry (STR). The Patients are selected from the Swedish National Patient Registry (NPR), and the Hospital Episode Statistics (HES)/NHS England using surgical and medical procedure codes known for requiring an anesthetic management in the form of general anesthesia, spinal/epidural anesthesia or regional anesthesia.

Eligible patients are associated with genotype data, and stratified into either homozygote/compound heterozygote, heterozygote, or wildtype to be able to assess whether a dose-response relationship exists between the different levels of exposures. From UKBB, a separate analysis of the association between red hair phenotype and perioperative complications is performed.

Outcome ascertainment, and the defining of cases and non-cases, is perfomed using healthcare linkage to Swedish Perioperative Registry (SPOR), Swedish Intensive Care Register (SIR), National cause of death registry (DORS), Statistics Sweden, and UKBB.

The results will be analyzed using a statistical mixed effects model, adjusted for age, sex, timing of surgery during the study period, and socioeconomic factors. The results of the genotype analysis from the two cohorts will be meta-analyzed.

Studietyp

Observationell

Inskrivning (Beräknad)

100000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Sverige
      • Uppsala, Sverige, 75185
        • Uppsala University, Department of Surgical Sciences
        • Kontakt:
        • Huvudutredare:
          • Miklós Lipcsey, MD, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

  • None specified.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Tidsram: Days 30 after a qualifying procedure.
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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Tidsram: Days 30 after a qualifying procedure.
The variables in the composite outcome analyzed one by one.
Days 30 after a qualifying procedure.
Adverse events registered at the post anesthesia care unit (PACU)
Tidsram: Hours 24 after a qualifying procedure.
Tachy-/bradycardia, arrythmia, angina, heart failure, hypo-/hypertension, and unexpected bleeding registered in the Swedish Perioperative Register (SPOR) from patients originating from the Swedish cohort.
Hours 24 after a qualifying procedure.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Uppsala University

Samarbetspartners

Dalarna County Council, Sweden
County Council of Gavleborg

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2026

Avslutad studie (Beräknad)

1 december 2026

Studieregistreringsdatum

Först inskickad

4 september 2026

Först inskickad som uppfyllde QC-kriterierna

10 september 2026

Första postat (Faktisk)

11 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • PRAMMIC-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The data that support the findings of this study are available from the respective national registries in Sweden with restrictions as defined by the General Data Protection Regulation (GDPR), the Swedish Personal Data Act (1998:204), and the licenses with the respective national registries, and so are not publicly available. Data are however available from the respective national registries after reasonable request and adequate permissions from the Swedish ethical review authority under the restrictions outlined above.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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