MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUppsala University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A qualifying surgical procedure requiring specified anesthetic management.
A qualifying medical procedure requiring specified anesthetic management.
Caucasian origin.
Disqualifiers
None specified.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
100,000 Participants
are grouped into 3 trial groupsGroup A: Exposure (high
Group B: Exposure (intermediate)
Group C: Non-exposure (control)
Trial outcomes
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.
Time frame
Days 30 after a qualifying procedure.Secondary outcomes
1
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
The variables in the composite outcome analyzed one by one.
Time frame
Days 30 after a qualifying procedure.2
Adverse events registered at the post anesthesia care unit (PACU)
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.
Time frame
Hours 24 after a qualifying procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
County Council of Gavleborg
Collaborator
Dalarna County Council, Sweden
Collaborator
Source ClinicalTrials.gov
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