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Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

NCT01809054 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2014-04-21

Study results available
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Summary

This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital:

1. Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
2. Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Conditions

  • Primary Total Hip and Knee Arthroplasty

Interventions

DRUG

Arixtra

DEVICE

Pneumatic compression stockings

Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)

DRUG

Aspirin

Sponsors & Collaborators

  • Haemonetics Corporation

    collaborator INDUSTRY

  • LifeBridge Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809054 on ClinicalTrials.gov