Venous ThromboembolismNCT05382481
Anti Xa Monitoring Low Molecular Weight Heparin on Prevention of Venous Thromboembolism
A study testing Peak value anti-Xa and Trough value anti-Xa in people with Venous Thromboembolism, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Peak value anti-Xa and Trough value anti-Xa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 858 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Chunmei Wang, 13681359526, drwangchunmei@sina.com
About this study
Official title: Effect of Anti Xa Monitoring Low Molecular Weight Heparin (LMWH) on Prevention of Venous Thromboembolism in Critically Ill Patients：A Randomized Controlled Trial
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.
Read the detailed description
Low molecular weight heparins (LMWH) are commonly used injectable anticoagulants for venous thromboembolism (VTE) prophylaxis and treatment. LMWH forms an inhibitory complex with antithrombin to inactivate activated factor X (Xa). Due to the predictable pharmacokinetics and pharmacodynamics of LMWH, it is not necessary to routinely monitor anti-Xa levels. However, LMWH pharmacokinetics and pharmacodynamics may be less predictable in certain patient populations including renal impairment, obesity, malignancy, or pregnancy .
Both increased risk of bleeding and suboptimal efficacy are possible in obese patients. LMWHs distribute into lean body mass, therefore, obese patients with a lower proportion of lean body mass to adipose tissue receiving LMWH dosed according to actual body weight may achieve supratherapeutic drug concentrations which could increase bleeding risk . On the other hand, fixed-dose VTE prophylaxis regimens do not account for higher body weight associated with obesity potentially resulting in subtherapeutic drug concentrations increasing the risk for therapeutic failure.
As LMWH are primarily renally eliminated, impaired renal function can contribute to drug accumulation and increased risk of major bleeding.The prolonged LMWH monotherapy used in cancer-associated VTE treatment also raises concerns about drug accumulation and increased bleeding, especially in those with fluctuating renal function. In addition, pregnancy can potentially increase the clearance and volume of distribution of LMWH, increasing the potential for subtherapeutic anti-Xa levels. Thus, anti-Xa level assays are often performed for these specific patient populations in an attempt to provide optimal LMWH therapy.
Critically ill patients are higher risk populations of VTE and bleeding with complex conditions, for example sedation, mechanical ventilation, central venous catheter, and have severe infection, renal insufficiency/failure. So, the purpose of this RCT is to explore the effect of anti Xa monitoring LMWH in preventing VTE in critically ill patients and the optimal time of anti Xa monitoring, reduce mortality and serious adverse events.
- Conditions
- Venous Thromboembolism
- Being tested
- Peak value anti-Xa, Trough value anti-Xa, Control Group
- Keywords
- venous thromboemboism, low molecular weight heparins, critically ill patients, anti-Xa, randomized controlled trial
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peak value anti-XaDiagnostic test
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-XaDiagnostic test
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 GroupDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Peak value anti-Xa group (Group A) | Experimental | The 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. Receives: Diagnostic Test: Peak value anti-Xa |
| Trough value anti-Xa group (Group B) | Experimental | The 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. Receives: Diagnostic Test: Trough value anti-Xa |
| Control group （Group C） | Placebo comparator | The 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. Receives: Diagnostic Test: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of VTE
VTE include symptomatic VTE or asymptomatic VTE at day 14
Measured: 14 days after randomization
Secondary outcomes (3)
number of targets reached of peak value or trough value of anti Xa for the first time
LMWH 40mg，once a day, 3 day later, the peak value or trough value of anti Xa for the first time
Measured: 14 days after randomization
number of hemorrhage
Major hemorrhage include 1)symptomatic hemorrhage in a major organ such as intracranial hemorrhage, intra spinal, intraocular, retro peritoneal, intra-articular, pericardial and muscle bleeding causing a compartment syndrome; 2)symptomatic hemorrhage causing a fall in hemoglobin of at least 2 g / dL or leading to a transfusion of at least two blood unit.
Measured: 14 days after randomization
number of all cause in-hospital death
Cause and date of death
Measured: 14 days and in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start16 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 858 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382481
- Sponsor's protocol ID
- 2022-2-2016
- Status last verified
- Apr 2023
- First submitted
- 15 May 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37880168
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Anti Xa Monitoring Low Molecular Weight Heparin (LMWH) on Prevention of Venous Thromboembolism in Critically Ill Patients：A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05382481
- Acronym / sponsor ID
- 2022-2-2016
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboemboism, low molecular weight heparins, critically ill patients, anti-Xa, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 858 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Peking University First Hospital
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low molecular weight heparins (LMWH) are commonly used injectable anticoagulants for venous thromboembolism (VTE) prophylaxis and treatment. LMWH forms an inhibitory complex with antithrombin to inactivate activated factor X (Xa). Due to the predictable pharmacokinetics and pharmacodynamics of LMWH, it is not necessary to routinely monitor anti-Xa levels. However, LMWH pharmacokinetics and pharmacodynamics may be less predictable in certain patient populations including renal impairment, obesity, malignancy, or pregnancy .
Both increased risk of bleeding and suboptimal efficacy are possible in obese patients. LMWHs distribute into lean body mass, therefore, obese patients with a lower proportion of lean body mass to adipose tissue receiving LMWH dosed according to actual body weight may achieve supratherapeutic drug concentrations which could increase bleeding risk . On the other hand, fixed-dose VTE prophylaxis regimens do not account for higher body weight associated with obesity potentially resulting in subtherapeutic drug concentrations increasing the risk for therapeutic failure.
As LMWH are primarily renally eliminated, impaired renal function can contribute to drug accumulation and increased risk of major bleeding.The prolonged LMWH monotherapy used in cancer-associated VTE treatment also raises concerns about drug accumulation and increased bleeding, especially in those with fluctuating renal function. In addition, pregnancy can potentially increase the clearance and volume of distribution of LMWH, increasing the potential for subtherapeutic anti-Xa levels. Thus, anti-Xa level assays are often performed for these specific patient populations in an attempt to provide optimal LMWH therapy.
Critically ill patients are higher risk populations of VTE and bleeding with complex conditions, for example sedation, mechanical ventilation, central venous catheter, and have severe infection, renal insufficiency/failure. So, the purpose of this RCT is to explore the effect of anti Xa monitoring LMWH in preventing VTE in critically ill patients and the optimal time of anti Xa monitoring, reduce mortality and serious adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peak value anti-Xa group (Group A) | Experimental | Diagnostic Test: Peak value anti-XaThe 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) | Experimental | Diagnostic Test: Trough value anti-XaThe 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 comparator | Diagnostic Test: Control GroupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peak value anti-XaThis 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. | Diagnostic test | Peak value anti-Xa group (Group A) |
| Trough value anti-XaThis 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. | Diagnostic test | Trough value anti-Xa group (Group B) |
| Control GroupThis group will receive fixed dose of low molecular weight heparins (LMWH) 40mg, once a day. And will not detect the level of anti-Xa | Diagnostic test | Control group （Group C） |
Primary outcome
number of VTE
Time frame: 14 days after randomization
VTE include symptomatic VTE or asymptomatic VTE at day 14
3 secondary outcomes
number of targets reached of peak value or trough value of anti Xa for the first time
Time frame: 14 days after randomization
number of hemorrhage
Time frame: 14 days after randomization
number of all cause in-hospital death
Time frame: 14 days and in hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 37880168Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peak value anti-Xa and Trough value anti-Xa in people with Venous Thromboembolism, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunmei Wang, MD (+0086-13681359526, drwangchunmei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of VTE (time frame: 14 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05382481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.