N/A N=411 Randomized Single-blind Prevention

Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Deep Vein Thrombosis of Lower Limb · Pulmonary Embolism (PE) · Bleeding

Bottom Line

View on ClinicalTrials.gov: NCT00358735 ↗

Enrolled (actual)

411

Serious AEs

3.3%

Results posted

Oct 2014

Primary outcome: Primary: Events of Deep Vein Thrombosis (DVT) — 8; 8; 5; 6 Events — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ActiveCare CECT device (Device); Enoxaparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical Compression Systems
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Events of Deep Vein Thrombosis (DVT)	8; 8; 5; 6; 3; 2	>0.05
PRIMARY Clinical PE (Pulmonary Embolism) Events	2; 2	>0.05
SECONDARY Major Bleeding Complication	0; 11	0.0004 sig
SECONDARY OutPatient Patients' Compliance	83	—
SECONDARY Serious Adverse Events	3; 10	—
SECONDARY In-Patients' Compliance	91	—

Summary

Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.

Eligibility Criteria

Inclusion Criteria

Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

Exclusion Criteria

Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.

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Data sourced from ClinicalTrials.gov (NCT00358735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.