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Ardeparin Sodium for Extended Out-of-Hospital Prophylaxis against Venous Thromboembolism after Total Hip or Knee Replacement: A Randomized, Double-Blind, Placebo-Controlled Trial

John A. Heit, MD; C. Gregory Elliott, MD; Arthur A. Trowbridge, MD; Bernard F. Morrey, MD; Michael Gent, DSc; Jack Hirsh, MD, Ardeparin Arthroplasty Study Group*
[+] Article, Author, and Disclosure Information

From the Mayo Clinic and Foundation, Rochester, Minnesota; LDS Hospital and the University of Utah School of Medicine, Salt Lake City, Utah; Texas A&M University College of Medicine, Temple, Texas; and McMaster University, Hamilton, Ontario, Canada.

Acknowledgments: The authors thank the surgical, nursing, pharmacy, and support staff at all the study sites. They also thank Dr. D. Scott Holloway and Ms. Joanne DiLiberto, Wyeth-Ayerst Research.

Grant Support: By Wyeth-Ayerst Research, Philadelphia, Pennsylvania.

Requests for Single Reprints: John A. Heit, MD, Hematology Research, Plummer 549, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.

Requests To Purchase Bulk Reprints (minimum, 100 copies): the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.

Current Author Addresses: Dr. Heit: Hematology Research, Plummer 549, Mayo Clinic, 200 First Street SW, Rochester, MN 55905.

Dr. Elliott: LDS Hospital, University of Utah, Eighth Avenue and C Street, Salt Lake City, UT 84143.

Dr. Trowbridge: Texas A&M University, 2401 South 31st Street, Temple, TX 76508.

Dr. Morrey: Mayo Clinic, 200 First Street, SW, Rochester, MN 55905.

Drs. Gent and Hirsh: Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.

Author Contributions: Conception and design: C.G. Elliott, B.F. Morrey, J.A. Heit, J. Hirsh.

Analysis and interpretation of the data: C.G. Elliott, A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.

Drafting of the article: A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.

Critical revision of the article for important intellectual content: C.G. Elliott, A.A. Trowbridge, M. Gent, J.A. Heit, J. Hirsh.

Final approval of the article: C.G. Elliott, A.A. Trowbridge, B.F. Morrey, J.A. Heit, J. Hirsh.

Provision of study materials or patients: C.G. Elliott, A.A. Trowbridge, J.A. Heit, B.F. Morrey.

Statistical expertise: M. Gent.

Administrative, technical, or logistic support: M. Gent.

Collection and assembly of data: C.G. Elliott, J.A. Heit.

Ann Intern Med. 2000;132(11):853-861. doi:10.7326/0003-4819-132-11-200006060-00002
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The optimal duration of prophylaxis against venous thromboembolism after elective total hip or knee replacement is uncertain. In previous clinical trials, prophylaxis was given until hospital discharge and ranged from 7 to 14 days. However, the prevalence of asymptomatic deep venous thrombosis at hospital discharge was still approximately 15% for patients who had total hip replacement and 30% for those who had total knee replacement (1). Because most patients are now discharged by the third or fourth postoperative day, in-hospital prophylaxis may be inadequate.

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Figure 1.
Flow diagram of study design, drug intervention, patient enrollment, patient withdrawal, discontinuation of prophylaxis with the study drug, and duration of follow-up.

THR = total hip replacement; TKR = total knee replacement; SC = subcutaneously.

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Figure 2.
Duration of part A ardeparin sodium prophylaxis according to out-of-hospital prophylaxis assignment, overall and among patients who had efficacy failure.
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Summary for Patients

Use of a New Form of the Blood Thinner Heparin Outside the Hospital To Prevent Blood Clots after Hip or Knee Replacement

The summary below is from the full report titled “ Ardeparin Sodium for Extended Out-of-Hospital Prophylaxis against Venous Thromboembolism after Total Hip or Knee Replacement. A Randomized, Double-Blind, Placebo-Controlled Trial.” It is in the 6 June 2000 issue of Annals of Internal Medicine (volume 132, pages 853-861). The authors are J.A. Heit, C.G. Elliott, A.A. Trowbridge, B.F. Morrey, M. Gent, and J. Hirsh, for the Ardeparin Arthroplasty Study Group.


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