Prophylaxis of Deep Vein Thrombosis Following Total Hip A... | NCT02379663

Studies
Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

NCT02379663

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Mar 5, 2015Estimated

Enrollment

639Actual

Phase

Phase 4

Conditions

Osteoarthritis, Hip
Femur Head Necrosis
Femoral Neck Fractures

Interventions

Rivaroxaban
Enoxaparin
Normal saline

Countries

Not provided

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

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Feb 13, 2015

First Submission Date that Met QC Criteria

Mar 4, 2015

First Posted Date

Mar 5, 2015Estimated

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

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

639Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral direct Factor Xa inhibitor	Active Comparator	Rivaroxaban	Drug: Rivaroxaban
Low molecular weight heparin	Active Comparator	Enoxaparin	Drug: Enoxaparin
Normal Saline	Placebo Comparator	Normal Saline	Other: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	Rivaroxaban was taken orally in a dosage of 10mg once daily	Oral direct Factor Xa inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major wound complication	hematoma : size, site woozing : frequency, amount, dressing change count infection : culture	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA

Exclusion Criteria:

recent history of active bleeding or VTE
known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
major surgery in the prior three months
renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned indwelling epidural catheter for > 6 hours after the end of surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015207	Osteoarthritis, Hip
D005271	Femur Head Necrosis
D005265	Femoral Neck Fractures

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban
D017984	Enoxaparin
D000077330	Saline Solution

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

Browse Leaves

Not provided

Browse Branches

Not provided