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Completed

NCT Number: NCT01809054

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

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.

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Key information

Conditions

Primary Total Hip and Knee Arthroplasty Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women age ≥ 18 years old
  • Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Exclusion criteria

  • Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
  • History of bleeding diathesis
  • Known active malignancy
  • Prothrombin time >1.5 x control
  • Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min
  • Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis
  • Major surgery within past 3 months of enrollment
  • Patients requiring bilateral arthroplasty
  • Body weight <50 kg (venous thromboembolism prophylaxis only)
  • Unable to return to site for follow-up visit

Treatment and study plan

Arixtra

Drug

Pneumatic Compression Stockings

Device

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

Aspirin

Drug

Primary outcomes

  1. Blood Loss

    Time frame: 6 weeks

    requiring transfusion

Secondary outcomes

  1. Deep Vein Thrombosis

    Time frame: 6 weeks

    verified by ultrasound

Sponsors and collaborators

Lead sponsor

LifeBridge Health

Other

Collaborators

  • Haemonetics Corporation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2013
Registry last updated
Apr 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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