Anti Xa Monitoring Low Molecular Weight Heparin on Prevention of Venous Thromboembolism
Effect of Anti Xa Monitoring Low Molecular Weight Heparin (LMWH) on Prevention of Venous Thromboembolism in Critically Ill Patients：A Randomized Controlled Trial
1 other identifier
interventional
858
1 country
1
Brief Summary
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism, is a common cardiovascular disease associated with significant morbidity ranging from painful leg swelling, chest pain, shortness of breath, and even death. About 50% of all VTE events occur as a result of a current or recent hospital admission for surgery or acute medical illness. Hospital-acquired VTE is preventable, with interventions including anticoagulants and mechanical measures, including compression stockings and intermittent pneumatic compression. Prevented hospital acquired VTE is the focus of health services and the strongest hospital strategy to improve patient health in the world.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2022
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedApril 5, 2023
April 1, 2023
2.6 years
May 15, 2022
April 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of VTE
VTE include symptomatic VTE or asymptomatic VTE at day 14
14 days after randomization
Secondary Outcomes (3)
number of targets reached of peak value or trough value of anti Xa for the first time
14 days after randomization
number of hemorrhage
14 days after randomization
number of all cause in-hospital death
14 days and in hospital
Study Arms (3)
Peak value anti-Xa group (Group A)
EXPERIMENTALThe peak value of anti-Xa level of this group should be remain 0.3～0.5IU/mL. This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the peak level of anti-Xa after 4 to 6 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the peak value of anti Xa.
Trough value anti-Xa group (Group B)
EXPERIMENTALThe trough value of anti-Xa level of this group should be remain 0.1～0.2IU/mL. This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the trough level of anti-Xa after 12 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the trough value of anti Xa.
Control group （Group C）
PLACEBO COMPARATORThe control group will not detect the value of anti Xa and not adjust the dose of LMWH. This group will receive fixed dose of low molecular weight heparins (LMWH) 40mg, once a day.
Interventions
This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the peak level of anti-Xa after 4 to 6 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the peak value of anti Xa.
This group will receive low molecular weight heparins (LMWH) 40mg, once a day for the first 3 days. And detect the trough level of anti-Xa after 12 hours after injection of the third dose of LMWH. Adjust the dose of LMWH according to the trough value of anti Xa.
This group will receive fixed dose of low molecular weight heparins (LMWH) 40mg, once a day. And will not detect the level of anti-Xa
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- No gender limited
- Prospectively screened for risk and included if they received LMWH
- The patient or his / her legal representative is able and willing to sign the informed consent
You may not qualify if:
- History of hemorrhage or high risk of hemorrhage, including subarachnoid hemorrhage, cerebral hemorrhage, traumatic brain injury, blood system diseases, etc
- Severe renal insufficiency before randomization (creatinine clearance rate (CCr) \< 30mL/min)
- Expected length of ICU stay less than 3 days
- Known to be allergic to LMWH
- Pregnancy
- History of heparin induced thrombocytopenia
- Patients with iliac vein compression syndrome
- Receive non LMWH for prevention VTE according to the physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xuanwu Hospital, Beijinglead
- Peking University First Hospitalcollaborator
Study Sites (1)
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053, China
Related Publications (1)
Wang C, Ning YC, Song LP, Li PJ, Wang FH, Ding MX, Jiang L, Wang M, Pei QQ, Hu SM, Wang H. 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. BMJ Open. 2023 Oct 25;13(10):e069742. doi: 10.1136/bmjopen-2022-069742.
PMID: 37880168DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2022
First Posted
May 19, 2022
Study Start
May 16, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share