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

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ClinicalTrials.gov Identifier: NCT01809054
Recruitment Status : Completed
First Posted : March 12, 2013
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Haemonetics Corporation
Information provided by (Responsible Party):
LifeBridge Health

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Total Hip and Knee Arthroplasty Drug: Arixtra Device: Pneumatic compression stockings Drug: Aspirin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
Study Start Date : April 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arixtra Arm
Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Drug: Arixtra
Drug: Aspirin
Active Comparator: Pneumatic compression stockings arm
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.
Device: Pneumatic compression stockings
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)

Drug: Aspirin



Primary Outcome Measures :
  1. Blood Loss [ Time Frame: 6 weeks ]
    requiring transfusion


Secondary Outcome Measures :
  1. Deep Vein Thrombosis [ Time Frame: 6 weeks ]
    verified by ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809054


Locations
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United States, Maryland
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Sinai Center for Thrombosis Research
Baltimore, Maryland, United States, 21215
Sponsors and Collaborators
LifeBridge Health
Haemonetics Corporation

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Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT01809054     History of Changes
Other Study ID Numbers: 1888
First Posted: March 12, 2013    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Keywords provided by LifeBridge Health:
Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss

Additional relevant MeSH terms:
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Aspirin
PENTA
Fondaparinux
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Anticoagulants