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Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery

NCT00767559 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2011-09-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

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)

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.

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.

Sponsors & Collaborators

  • The New England Baptist Hospital

    lead OTHER

Principal Investigators

  • Murray Bern, MD · New England Baptist Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00767559 on ClinicalTrials.gov