Anti-factor Xa level monitoring of low-molecular-weight heparin for prevention of venous thromboembolism in critically ill patients (AXaLPE) : protocol of a randomised, open-label controlled clinical trial
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
INTRODUCTION: Whether and when to monitor the amount of anti-factor Xa (aFXa) activity in critically ill patients with complex diseases to prevent venous thromboembolism (VTE) remain unclear. This study is a randomised controlled trial to investigate the effect of aFXa level monitoring on reducing VTE and to establish a new method for accurately preventing VTE in critically ill patients with low-molecular-weight heparin (LMWH).
METHODS AND ANALYSIS: A randomised controlled trial is planned in two centres with a planned sample size of 858 participants. Participants will be randomly assigned to three groups receiving LMWH prophylaxis at a 1:1:1 ratio: in group A, peak aFXa levels will serve as the guide for the LMWH dose; in group B, the trough aFXa levels will serve as the guide for the LMWH dose; and in group C, participants serving as the control group will receive a fixed dose of LMWH. The peak and trough aFXa levels will be monitored after LMWH (enoxaparin, 40 mg, once daily) reaches a steady state for at least 3 days. The monitoring range for group A's aFXa peak value will be 0.3-0.5 IU/mL, between 0.1 and 0.2 IU/mL is the target range for group B's aFXa trough value. In order to reach the peak or trough aFXa levels, groups A and B will be modified in accordance with the monitoring peak and trough aFXa level. The incidence of VTE will serve as the study's primary outcome indicator. An analysis using the intention-to-treat and per-protocol criterion will serve as the main outcome measurement.
ETHICS AND DISSEMINATION: The Xuanwu Hospital Ethics Committee of Capital Medical University and Peking University First Hospital Ethics Committee have approved this investigation. It will be released in all available worldwide, open-access, peer-reviewed publications.
TRIAL REGISTRATION NUMBER: NCT05382481.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
BMJ open - 13(2023), 10 vom: 25. Okt., Seite e069742 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wang, Chunmei [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 13.11.2023 Date Revised 13.11.2023 published: Electronic ClinicalTrials.gov: NCT05382481 Citation Status MEDLINE |
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| doi: |
10.1136/bmjopen-2022-069742 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Anti-factor Xa level monitoring of low-molecular-weight heparin for prevention of venous thromboembolism in critically ill patients (AXaLPE) |b protocol of a randomised, open-label controlled clinical trial |
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| 500 | |a ClinicalTrials.gov: NCT05382481 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a INTRODUCTION: Whether and when to monitor the amount of anti-factor Xa (aFXa) activity in critically ill patients with complex diseases to prevent venous thromboembolism (VTE) remain unclear. This study is a randomised controlled trial to investigate the effect of aFXa level monitoring on reducing VTE and to establish a new method for accurately preventing VTE in critically ill patients with low-molecular-weight heparin (LMWH) | ||
| 520 | |a METHODS AND ANALYSIS: A randomised controlled trial is planned in two centres with a planned sample size of 858 participants. Participants will be randomly assigned to three groups receiving LMWH prophylaxis at a 1:1:1 ratio: in group A, peak aFXa levels will serve as the guide for the LMWH dose; in group B, the trough aFXa levels will serve as the guide for the LMWH dose; and in group C, participants serving as the control group will receive a fixed dose of LMWH. The peak and trough aFXa levels will be monitored after LMWH (enoxaparin, 40 mg, once daily) reaches a steady state for at least 3 days. The monitoring range for group A's aFXa peak value will be 0.3-0.5 IU/mL, between 0.1 and 0.2 IU/mL is the target range for group B's aFXa trough value. In order to reach the peak or trough aFXa levels, groups A and B will be modified in accordance with the monitoring peak and trough aFXa level. The incidence of VTE will serve as the study's primary outcome indicator. An analysis using the intention-to-treat and per-protocol criterion will serve as the main outcome measurement | ||
| 520 | |a ETHICS AND DISSEMINATION: The Xuanwu Hospital Ethics Committee of Capital Medical University and Peking University First Hospital Ethics Committee have approved this investigation. It will be released in all available worldwide, open-access, peer-reviewed publications | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05382481 | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Adult intensive & critical care | |
| 650 | 4 | |a Anticoagulation | |
| 650 | 4 | |a INTENSIVE & CRITICAL CARE | |
| 650 | 4 | |a Thromboembolism | |
| 650 | 7 | |a Anticoagulants |2 NLM | |
| 650 | 7 | |a Enoxaparin |2 NLM | |
| 650 | 7 | |a Heparin |2 NLM | |
| 650 | 7 | |a 9005-49-6 |2 NLM | |
| 650 | 7 | |a Heparin, Low-Molecular-Weight |2 NLM | |
| 650 | 7 | |a Factor Xa Inhibitors |2 NLM | |
| 700 | 1 | |a Ning, Ya-Chan |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Li-Po |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Pei-Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Feng-Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Ding, Meng-Xi |e verfasserin |4 aut | |
| 700 | 1 | |a Jiang, Li |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Meiping |e verfasserin |4 aut | |
| 700 | 1 | |a Pei, Qian-Qian |e verfasserin |4 aut | |
| 700 | 1 | |a Hu, Shi-Min |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Haibo |e verfasserin |4 aut | |
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