NCT00767559

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

2.9 years

First QC Date

October 3, 2008

Last Update Submit

September 23, 2011

Conditions

Pulmonary Embolism

Keywords

Deep Vein Thrombosis, anticoagulants, surgery, pulmonary embolus, warfarin, fondaparinox

Outcome Measures

Primary Outcomes (4)

  • Primary Outcome based upon intent to treat: Composite outcome of

    28 days

  • Ultrasound or venogram confirmed deep vein thrombosis.

    28 days

  • Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.

    28 days

  • Death due to TED

    28 days

Secondary Outcomes (10)

  • Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures

    28 days

  • Distribution of proximal vs distal deep vein thrombosis of the leg

    28 days

  • Amount of intraoperative bleeding

    follow until Dec. 31, 2010

  • 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.

    follow until Dec. 31, 2010

  • Number of ultrasounds and V/Q or CTA's required

    follow until Dec. 31, 2010

  • +5 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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:

3

ACTIVE COMPARATOR

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

Interventions

warfarinDRUG

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)

Also known as: Coumadin
1
Fondaparinux:DRUG

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.

Also known as: Arixtra
2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Surgery for acute fracture (\< 4 weeks), septic joint, or extraction arthroplasty.
  • Patients with personal history of TED, or documented hypercoagulation disease.
  • Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
  • Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
  • Liver enzymes or bilirubin greater than 2 x normal.
  • Decreased renal function with GFR \< 30ml/min. (24-27)
  • Cancer in last 1 year, other than localized cancers of the skin.
  • Requires chronic anticoagulation with warfarin or heparins.
  • Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
  • Prior adverse reaction to any of the study drugs.
  • Pregnancy
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (2)

  • Bern MM, Hazel D, Deeran E, Richmond JR, Ward DM, Spitz DJ, Mattingly DA, Bono JV, Berezin RH, Hou L, Miley GB, Bierbaum BE. Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study. Thromb J. 2015 Oct 7;13:32. doi: 10.1186/s12959-015-0062-0. eCollection 2015.

    PMID: 26448724DERIVED

  • Bern MM, Hazel D, Reilly DT, Adcock DM, Hou L. Effects of anticoagulation on markers of activation of clotting following major orthopedic surgery. Int J Lab Hematol. 2015 Oct;37(5):673-9. doi: 10.1111/ijlh.12384. Epub 2015 May 15.

    PMID: 25975205DERIVED

MeSH Terms

Conditions

Pulmonary EmbolismVenous Thrombosis

Interventions

WarfarinFondaparinux

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Murray Bern, MD

    New England Baptist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

US(1)