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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Miklós Lipcsey, MD, PhD
- 電話番号：0046 18 611 0000
- メール：miklos.lipcsey@uu.se
研究場所
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Uppsala、スウェーデン、75185
- Uppsala University, Department of Surgical Sciences
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コンタクト：
- Miklós Lipcsey, MD, PhD
- 電話番号：0046 18 6110000
- メール：miklos.lipcsey@uu.se
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主任研究者：
- Miklós Lipcsey, MD, PhD
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- A qualifying surgical procedure requiring specified anesthetic management.
- A qualifying medical procedure requiring specified anesthetic management.
- Caucasian origin.
Exclusion Criteria:
- None specified.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Serious adverse events occurring after a surgical, or medical procedure requiring anesthetic.
時間枠：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)
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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