Is Anti-Factor Xa Associated With Outcome in Patients With Critical COVID-19 on Low-Molecular-Weight Heparin? (AntiXCOVID)
Is Anti-Factor Xa Associated With Mortality, Thromboembolism and Bleeding in Patients With Critical COVID-19 Patients on Low-Molecular-Weight Heparin?
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
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Stockholm、スウェーデン、11883
- Södersjukhuset
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
All patients with critical COVID-19 and respiratory failure admitted to ICU at Södersjukhuset, Karolinska Sjukhuset and Skånes Universitetssjukhus, in Sweden, between March 1 2020 and May 31 2021 are eligible.
Patients will be included on their first admission to the ICU if admitted more than once. First admission can be replaced by the second one if the first one is considered very short/insignificant compared to the second one. If a patient is transferred from one ICU to another this will be considered the same admission but they will be grouped according to their initial ICU.
説明
Inclusion Criteria:
- Patients with critical COVID-19 and respiratory failure
- Positive SARS-CoV-2 test
- LMWH-effect monitored by aFXa, as a trough or peak value, after at least four doses at a twice daily regime
Exclusion Criteria:
- Diagnosed thromboembolism or major bleeding during their COVID-illness prior to ICU-admission or as a reason or contributing factor for the ICU-admission.
- Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible
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 |
介入・治療 |
|---|---|
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Patients with critical COVID-19 responding to LMWH treatment
Responders are defined as patient who achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.
|
Quantified by aFXa-levels
The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking
|
|
Patients with critical COVID-19 not responding to LMWH treatment
Non-responders are defined as patients who do not achieve aFXa-levels, peak or trough, within target-range as excepted from the given dose of LMWH.
|
Quantified by aFXa-levels
The frequency of aFXa-levels being sampled, analysed and integrated as a possible part of the basis for clinical decisionmaking
|
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 |
|---|---|---|
|
Mortality
時間枠：90 days from ICU admission
|
90-day mortality
|
90 days from ICU admission
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Thromboembolic events
時間枠：28 days from ICU-admission
|
Thromboembolic events are defined as the cumulative proportion of pulmonary embolism (PE), ischemic stroke and deep venous thrombosis (DVT). PE must be verified by computed tomography or by clinical suspicion as cause of deterioration combined with findings of acute strain of the right heart on echocardiography. Ischemic stroke must be verified by computed tomography. DVT must by verified by ultrasound or by computed tomography. |
28 days from ICU-admission
|
|
Bleeding events
時間枠：28 days from ICU-admission
|
Bleeding events are categorized according to the World health organization (WHO) bleeding scale: 1) Petechiae, tissue hematoma, oropharyngeal bleeding, 2) Mild blood loss, hematemesis, macroscopic hematuria, hemoptysis, joint bleeding, 3) Gross blood loss requiring red blood cell transfusion and/or hemodynamic instability, 4) Debilitating blood loss, severe hemodynamic instability, fatal bleeding, or central nervous system bleeding.
|
28 days from ICU-admission
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Sandra Jonmarker, MD、Stockholm South General Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AntiFactorXa in Covid-19
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。