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N/A Completed 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
Source: ClinicalTrials.gov NCT00358735 ↗
Enrolled (actual)
411
Serious AEs
3.3%
Results posted
Oct 2014
Primary outcomePrimary: Events of Deep Vein Thrombosis (DVT) — 8; 8; 5; 6 Events — p=>0.05

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.

Outcome Measures

OutcomeResultp-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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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