CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
Arixtra +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01809054
NCT01809054Phase 4Completed
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Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

LifeBridge Health·interventional·Posted Mar 12, 2013·Updated Apr 21, 2014

In Brief

A Phase 4 clinical trial evaluating Arixtra, Pneumatic compression stockings, and 1 other intervention for Primary Total Hip and Knee Arthroplasty. Completed, enrolled 54 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Total Hip and Knee Arthroplasty
CountriesUnited States
CollaboratorsHaemonetics Corporation

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2013
Enrollment StartApr 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.3 years ago

Interventions

Arixtradrug

Pneumatic compression stockingsdevice

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

Aspirindrug