Anaesthesia ComplicationMARPACNCT07815431
MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications
An observational study of Anaesthesia Complication and Perioperative Adverse Events, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anaesthesia Complication, Perioperative Adverse Events, Red Hair
- How many people
- 100,000 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- A qualifying surgical procedure requiring specified anesthetic management.
- A qualifying medical procedure requiring specified anesthetic management.
- Caucasian origin.
Who cannot join
- None specified.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Uppsala University, Department of Surgical Sciences
Uppsala, 75185
Miklós Lipcsey, MD, PhD, 0046 18 6110000, miklos.lipcsey@uu.se
Miklós Lipcsey, MD, PhD
About this study
Official title: 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.
Read the detailed description
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.
- Keywords
- Red hair, Anesthesia, Surgery, Perioperative complications, Adverse events, Melanocortin 1 receptor mutation, MC1R
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 30 after a qualifying procedure.
Secondary outcomes (2)
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
The variables in the composite outcome analyzed one by one.
Measured: Days 30 after a qualifying procedure.
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.
Measured: Hours 24 after a qualifying procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaesthesia ComplicationStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- County Council of Gavleborg, Dalarna County Council, Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815431
- Sponsor's protocol ID
- PRAMMIC-001
- Acronym
- MARPAC
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of Red Hair Associated MC1R Mutations and the Incidence of Perioperative Anesthesia Complications: A Cohort Study
- ClinicalTrials.gov ID
- NCT07815431
- Acronym / sponsor ID
- MARPAC / PRAMMIC-001
- Keywords
- Red hair, Anesthesia, Surgery, Perioperative complications, Adverse events, Melanocortin 1 receptor mutation, MC1R
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- County Council of Gavleborg, Dalarna County Council, Sweden
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- A qualifying surgical procedure requiring specified anesthetic management.
- A qualifying medical procedure requiring specified anesthetic management.
- Caucasian origin.
Key exclusion criteria (1 listed)
- None specified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Time frame: 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.
2 secondary outcomes
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Time frame: Days 30 after a qualifying procedure.
Adverse events registered at the post anesthesia care unit (PACU)
Time frame: Hours 24 after a qualifying procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaesthesia Complication and Perioperative Adverse Events, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miklós Lipcsey, MD, PhD (0046 18 611 0000, miklos.lipcsey@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic. (time frame: Days 30 after a qualifying procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.