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Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury (FARDS)

2026年7月1日 更新者：Eman Mohammed Taher Salem Abo-Omar、Tanta University

Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Patients With Traumatic Brain Injury: The Prospective, Observational, Multi-center FARDS Study

this study aims to assess the ability of fibrinogen-to-albumin ratio to predict the development of Acute respiratory distress syndrome in traumatic brain injury patients.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

Traumatic brain injury is a major cause of morbidity and mortality worldwide and represents a significant challenge in intensive care units. In addition to the primary neurological damage, patients with moderate to severe traumatic brain injury frequently develop systemic inflammatory responses that may lead to secondary organ dysfunction. These systemic effects are mediated by activation of inflammatory cytokines, endothelial injury, and coagulation abnormalities.

Acute respiratory distress syndrome is a common and serious complication in patients with traumatic brain injury, even in the absence of direct chest trauma. Epidemiological studies indicate that acute respiratory distress syndrome develops in approximately 19-30% of severe traumatic brain injury patients, typically within the first week after injury, with a median time to onset of around 3 days.

The fibrinogen-to-albumin ratio has recently emerged as a novel biomarker reflecting both inflammatory and nutritional status. Fibrinogen is a positive acute-phase reactant that increases in response to inflammation and tissue injury, while albumin is a negative acute-phase protein that decreases during systemic inflammatory states. Previous studies have demonstrated that fibrinogen-to-albumin ratio is altered in patients with traumatic brain injury and correlates with injury severity and clinical outcomes.

Given that the same inflammatory and coagulation pathways influencing fibrinogen-to-albumin ratio in traumatic brain injury also play a central role in the development of acute respiratory distress syndrome, it is biologically plausible that early fibrinogen-to-albumin ratio measurements may predict acute respiratory distress syndrome occurrence in this patient population. However, the predictive value of fibrinogen-to-albumin ratio for acute respiratory distress syndrome in patients with traumatic brain injury has not yet been adequately investigated.

研究の種類

観察的

入学 (推定)

350

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • エジプト
    • Gharbia Governorate
      • Tanta、Gharbia Governorate、エジプト、31527
        • 募集
        • Tanta University Hospitals
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

確率サンプル

調査対象母集団

Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.

説明

Inclusion Criteria:

  • Patients ≥ 18 years admitted to the ICU with traumatic Brain Injury
  • Admission to the ICU within 24 hours of injury.
  • Patients will be expected to remain under hospital care for follow-up
  • Availability of fibrinogen and albumin measurements within the first 24 hours of ICU admission.
  • Informed consent will be obtained from a legally authorized representative.

Exclusion Criteria:

  • Preexisting advanced chronic liver disease, nephrotic syndrome, or protein-losing enteropathy.
  • Pre-existing ARDS on admission.
  • Recipient of albumin, fibrinogen concentrate, or cryoprecipitate before admission sampling.
  • Use of anticoagulant or fibrinolytic therapy before admission.
  • Active malignancy or severe systemic infection at admission.
  • Direct sever lung injury
  • Pregnancy
  • Refusal of consent

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
介入・治療
Acute respiratory distress syndrome group

patients who will develop ARDS within 7 days of ICU admission, defined according to the Berlin criteria. Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
診断テスト：Fibrinogen-to-albumin ratio

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
Non acute respiratory distress syndrome group

patients who will not develop ARDS within 7 days of ICU admission. Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)
診断テスト：Fibrinogen-to-albumin ratio

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission.

Fibrinogen-to-albumin ratio will be calculated as:

FAR = Fibrinogen (g/L)/Albumin (g/L)

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
The accuracy of early fibrinogen-to-albumin ratio (within 24 hours of ICU admission) to predict the development of acute respiratory distress syndrome in traumatic brain injury patients.
時間枠：up to 7 days after traumatic brain injury.
Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)
up to 7 days after traumatic brain injury.

二次結果の測定

結果測定
メジャーの説明
時間枠
Incidence of acute respiratory distress syndrome
時間枠：up to 7 days after traumatic brain injury.
Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.
up to 7 days after traumatic brain injury.
Severity of acute respiratory distress syndrome.
時間枠：up to 7 days after traumatic brain injury.
It will be evaluated by the PaO2/FiO2 ratio. PaO2/FiO2 ratio between 200 and 300 will be considered mild ARDS. PaO2/FiO2 ratio between 200 and 100 will be considered moderate ARDS. PaO2/FiO2 ratio less than 100 will be considered severe ARDS.
up to 7 days after traumatic brain injury.
Duration of mechanical ventilation
時間枠：Up to 30 days after traumatic brain injury.
patients who will require mechanical ventilation for management of hypoxemia will be evaluated for the duration of mechanical ventilation.
Up to 30 days after traumatic brain injury.
ICU length of stay and mortality rate
時間枠：Up to 90 days after traumatic brain injury.
Death during ICU stay or thereafter will be recorded.
Up to 90 days after traumatic brain injury.
The accuracy of fibrinogen-to-albumin ratio measured at 24 hours and 48 hours after injury to predict the development of acute respiratory distress syndrome in traumatic brain injury patients.
時間枠：up to 7 days after traumatic brain injury.
Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured at 24 hours and 48 hours after injury. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)
up to 7 days after traumatic brain injury.
Predictive accuracy of delta fibrinogen-to-albumin ratio for the development of acute respiratory distress syndrome
時間枠：up to 7 days after traumatic brain injury.

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured on admission and at 24 hours and 48 hours after injury. Delta fibrinogen-to-albumin ratio will be calculated as:

Delta FAR (24h-0h) = FAR at 24h -FAR on admission Delta FAR (48h-0h) = FAR at 48h -FAR on admission Delta FAR (48h-24h)= FAR at 48h -FAR at 24h
up to 7 days after traumatic brain injury.
Association of fibrinogen-to-albumin ratio with neurological outcomes at 3 months after injury
時間枠：Up to 90 days after traumatic brain injury.
Neurological outcomes will be assessed by the Glasgow Outcome Score (GOS). The score is as follows: 1 = dead; 2 = vegetative state with an inability to interact with the environment; 3 = severe disability with an inability to live independently but the ability to follow commands; 4 = moderate disability with the ability to live independently but an inability to return to work or school; and 5 = good recovery with the ability to return to work or school. A GOS of 1-3 was categorized as an unfavorable outcome, whereas a score of 4-5 was deemed a favorable outcome.
Up to 90 days after traumatic brain injury.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Tanta University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月1日

一次修了 (推定)

2026年10月1日

研究の完了 (推定)

2027年1月1日

試験登録日

最初に提出

2026年6月17日

QC基準を満たした最初の提出物

2026年6月17日

最初の投稿 (実際)

2026年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年7月1日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 36265PR26/4/26

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?

はい

IPD プランの説明

The data will be available upon a reasonable request from the corresponding author after the end of the study for one year.

IPD 共有時間枠

After the end of the study for one year.

IPD 共有アクセス基準

The data will be available upon a reasonable request from the corresponding author.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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