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
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Miklós Lipcsey, MD, PhD
- 电话号码:0046 18 611 0000
- 邮箱:miklos.lipcsey@uu.se
学习地点
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Uppsala、瑞典、75185
- Uppsala University, Department of Surgical Sciences
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接触:
- Miklós Lipcsey, MD, PhD
- 电话号码:0046 18 6110000
- 邮箱:miklos.lipcsey@uu.se
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首席研究员:
- Miklós Lipcsey, MD, PhD
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- A qualifying surgical procedure requiring specified anesthetic management.
- A qualifying medical procedure requiring specified anesthetic management.
- Caucasian origin.
Exclusion Criteria:
- None specified.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
大体时间: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)
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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