Critically IllNCT03311984
Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China
An observational study of Critically Ill and Anti-Xa, run by Southeast University, China at 1 site in China.
Trial summary
Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite receiving of a standard dose of Low-molecular-weight Heparin（LMWH）, many patients still develop life-threatening embolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Anti-Xa
- What is being tested?
- anti Xa level
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2017to 30 May 2018
- Phase
- Observational
- 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
Study population: Adult Critically ill patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis.
Who may be able to join
- Adult Critically ill patients
Who cannot join
- Contraindication to use of LMWH. Intracranial bleeding/stroke, hematoma or bleeding disorder. Use Heparin anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China
Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite receiving of a standard dose of Low-molecular-weight Heparin（LMWH）, many patients still develop life-threatening embolism. The purpose of this study is to evaluate the anti-Xa levels of different dosing regimens of LMWH in critically ill patients in China.
- Conditions
- Critically Ill, Anti-Xa
- Being tested
- anti Xa level
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti Xa levelDiagnostic test
monitoring the anti-Xa level according to LMWH emploing
| Study group | Role | What they receive |
|---|---|---|
| LMWH qd | receiving Low-molecular-weight Heparin（LMWH）qd Receives: Diagnostic Test: anti Xa level | |
| LMWH q12h | receiving Low-molecular-weight Heparin（LMWH）q12h Receives: Diagnostic Test: anti Xa level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Xa Levels
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start15 Aug 2017
- Primary completion30 Mar 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun Pan, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311984
- Sponsor's protocol ID
- Anti-Xa Level
- Status last verified
- Oct 2017
- First submitted
- 6 Oct 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China
- ClinicalTrials.gov ID
- NCT03311984
- Acronym / sponsor ID
- Anti-Xa Level
- Conditions
- Critically Ill, Anti-Xa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 30 Mar 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 17 Oct 2017 (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.
Critically ill Patients are at high risk to develop deep venous thrombosis. However, despite receiving of a standard dose of Low-molecular-weight Heparin（LMWH）, many patients still develop life-threatening embolism. The purpose of this study is to evaluate the anti-Xa levels of different dosing regimens of LMWH in critically ill patients in China.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LMWH qd | – | Diagnostic Test: anti Xa levelreceiving Low-molecular-weight Heparin（LMWH）qd |
| LMWH q12h | – | Diagnostic Test: anti Xa levelreceiving Low-molecular-weight Heparin（LMWH）q12h |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Critically ill patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis.
Key inclusion criteria (1 listed)
- Adult Critically ill patients
Key exclusion criteria (1 listed)
- Contraindication to use of LMWH. Intracranial bleeding/stroke, hematoma or bleeding disorder. Use Heparin anticoagulant therapy
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 |
|---|---|---|
| anti Xa levelmonitoring the anti-Xa level according to LMWH emploing | Diagnostic test | LMWH q12h, LMWH qd |
Primary outcome
Anti-Xa Levels
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
Related trials for Critically Ill
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Not yet recruiting
Pilot Trial of Ambient Listening for Intensive Care Unit Family Meeting Summaries
Documentation of Serious Illness Communication for Critically Ill Patients
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
RecruitingPhase 3
Ketamine Sedation in the ICU (KANINE) RCT
Mechanical Ventilation, Critically Ill Intensive Care Unit Patients
RecruitingObservational study
Immunosuppression and Intensive Care Unit-acquired Multidrug-resistant Bacteria
Critically-ill Patients
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill and Anti-Xa, run by Southeast University, China 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 1 inclusion and 1 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 17 Oct 2017. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-Xa Levels (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.