MC1R Mutations Associated With Red Hair and Perioperative Anesthesia Complications (MARPAC)
The Presence of Red Hair Associated MC1R Mutations and the Incidence of Perioperative Anesthesia Complications: A Cohort Study
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Miklós Lipcsey, MD, PhD
- Número de teléfono: 0046 18 611 0000
- Correo electrónico: miklos.lipcsey@uu.se
Ubicaciones de estudio
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Uppsala, Suecia, 75185
- Uppsala University, Department of Surgical Sciences
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Contacto:
- Miklós Lipcsey, MD, PhD
- Número de teléfono: 0046 18 6110000
- Correo electrónico: miklos.lipcsey@uu.se
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Investigador principal:
- Miklós Lipcsey, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- A qualifying surgical procedure requiring specified anesthetic management.
- A qualifying medical procedure requiring specified anesthetic management.
- Caucasian origin.
Exclusion Criteria:
- None specified.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Exposure (high
Individuals from either MAICS or UKBB being homozygote/compound heterozygote for MC1R mutations, OR individuals from UKBB consistently reporting red hair phenotype.
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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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Periodo de tiempo: Days 30 after a qualifying procedure.
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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.
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Days 30 after a qualifying procedure.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
Periodo de tiempo: Days 30 after a qualifying procedure.
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The variables in the composite outcome analyzed one by one.
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Days 30 after a qualifying procedure.
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Adverse events registered at the post anesthesia care unit (PACU)
Periodo de tiempo: Hours 24 after a qualifying procedure.
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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.
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Hours 24 after a qualifying procedure.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- PRAMMIC-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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