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Anticoagulant

1 for Pulmonary Embolism (DVT Trial)

N/A
Waitlist Available
Led By Murray Bern, MD
Research Sponsored by The New England Baptist Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow until dec. 31, 2010
Awards & highlights

DVT Trial 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.

Eligible Conditions
  • Pulmonary Embolism

DVT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow until dec. 31, 2010
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow until dec. 31, 2010 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Death due to TED
Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.
Ultrasound or venogram confirmed deep vein thrombosis.
+1 more
Secondary outcome measures
Amount of intraoperative bleeding
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.
Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications
+7 more

DVT Trial Design

3Treatment groups
Active Control
Group I: 1Active Control1 Intervention
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)
Group II: 2Active Control1 Intervention
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.
Group III: 3Active Control1 Intervention
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).

Find a Location

Who is running the clinical trial?

The New England Baptist HospitalLead Sponsor
9 Previous Clinical Trials
2,814 Total Patients Enrolled
Murray Bern, MDPrincipal InvestigatorNew England Baptist Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~20 spots leftby Apr 2025