Anti-Xa Levels in Critically Ill Patients Receiving Low-m... | NCT03311984

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

NCT03311984

Sponsor

Southeast University, China

Status

Unknown status

Last Update Posted

Oct 17, 2017Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Critically Ill
Anti-Xa

Interventions

anti Xa level

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2017Actual

Primary Completion Date

Mar 30, 2018Estimated

Completion Date

May 30, 2018Estimated

First Submitted Date

Oct 6, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2017

Last Update Posted Date

Oct 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. The purpose of this study is to evaluate the anti-Xa levels of different dosing regimens of LMWH in critically ill patients in China.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LMWH qd		receiving Low-molecular-weight Heparin（LMWH）qd	Diagnostic Test: anti Xa level
LMWH q12h		receiving Low-molecular-weight Heparin（LMWH）q12h	Diagnostic Test: anti Xa level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti Xa level	Diagnostic Test	monitoring the anti-Xa level according to LMWH emploing	LMWH q12h LMWH qd

Measure	Description	Time Frame
Anti-Xa Levels		six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Critically ill patients

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changde Wu		Nanjing	Jiangsu	210029	China

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided