Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by The New England Baptist Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The New England Baptist Hospital
ClinicalTrials.gov Identifier:
NCT00767559
First received: October 3, 2008
Last updated: September 23, 2011
Last verified: September 2011
  Purpose

The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.

Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.


Condition Intervention
Pulmonary Embolism
Drug: warfarin
Drug: Fondaparinux:

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities

Resource links provided by NLM:


Further study details as provided by The New England Baptist Hospital:

Primary Outcome Measures:
  • Primary Outcome based upon intent to treat: Composite outcome of [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Ultrasound or venogram confirmed deep vein thrombosis. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Death due to TED [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Distribution of proximal vs distal deep vein thrombosis of the leg [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Amount of intraoperative bleeding [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: Yes ]
  • Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events. [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: Yes ]
  • Number of ultrasounds and V/Q or CTA's required [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: No ]
  • Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: Yes ]
  • Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit. [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: No ]
  • Death due to any other cause than TED [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: Yes ]
  • Use of low molecular weight dextran [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: No ]
  • Use of nonsteroidal anti-inflammatory drugs [ Time Frame: follow until Dec. 31, 2010 ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: November 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1

Variable dose warfarin: 5 mg beginning the night before surgery, followed by 5mg the PM of surgery*, and then variable daily dose,until day 30 follow-up.

(target INR 2.0-2.5)

Drug: warfarin
5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 28 (+/-2 days) from day of surgery follow-up. (target INR 2.0 -2.5)
Other Name: Coumadin
Active Comparator: 2

Fondaparinux:

2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*,or 6-8 hours after epidural catheter removal, and continued until follow-up (28 days +/-2) from day of surgery.

Drug: Fondaparinux:
2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*, or 6-8 hours after epidural catheter removal, and continued until follow up day 28 (+/-2 days) from day of surgery.
Other Name: Arixtra
Active Comparator: 3

Fixed Low Dose warfarin

1 mg daily beginning 7 days preoperative, and continued at 1 mg daily follow-up at Day 28 (+/-2 days from surgery).

Drug: warfarin

Fixed Low Dose warfarin

1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until follow-up 28 day (+/- 2 days) from day of surgery.

Other Name: coumadin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Planned for elective arthroplasty for knee and hip disease.
  2. Over 20 years of age.
  3. Normal baseline platelet count, prothrombin and partial thromboplastin times.
  4. Signed consent.

Exclusion Criteria:

  1. Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
  2. Patients with personal history of TED, or documented hypercoagulation disease.
  3. Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
  4. Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
  5. Liver enzymes or bilirubin greater than 2 x normal.
  6. Decreased renal function with GFR < 30ml/min. (24-27)
  7. Cancer in last 1 year, other than localized cancers of the skin.
  8. Requires chronic anticoagulation with warfarin or heparins.
  9. Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
  10. Prior adverse reaction to any of the study drugs.
  11. Pregnancy
  12. Uncontrolled hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767559

Locations
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
Principal Investigator: Murray Bern, MD New England Baptist Hospital
  More Information

No publications provided

Responsible Party: Murray Bern, MD, New England Baptist Hostpital
ClinicalTrials.gov Identifier: NCT00767559     History of Changes
Other Study ID Numbers: NEBH 2008-016
Study First Received: October 3, 2008
Last Updated: September 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The New England Baptist Hospital:
Deep Vein Thrombosis, anticoagulants, surgery, pulmonary embolus, warfarin, fondaparinox

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fondaparinux
PENTA
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014