Anti-Xa Levels in Critically Ill Patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis in China

October 16, 2017 updated by: Chun Pan, Southeast University, China

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Changde Wu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult Critically ill patients Receiving Low-molecular-weight Heparin for Thromboprophylaxis.

Description

Inclusion Criteria:

  • Adult Critically ill patients

Exclusion Criteria:

  • Contraindication to use of LMWH. Intracranial bleeding/stroke, hematoma or bleeding disorder. Use Heparin anticoagulant therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LMWH qd
receiving Low-molecular-weight Heparin（LMWH）qd
Diagnostic test: anti Xa level
monitoring the anti-Xa level according to LMWH emploing
LMWH q12h
receiving Low-molecular-weight Heparin（LMWH）q12h
Diagnostic test: anti Xa level
monitoring the anti-Xa level according to LMWH emploing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-Xa Levels
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southeast University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Anticipated)

March 30, 2018

Study Completion (Anticipated)

May 30, 2018

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anti-Xa Level

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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