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Brief Summary

GUIDELINE TITLE

Outpatient management of uncomplicated deep venous thrombosis.

BIBLIOGRAPHIC SOURCE(S)

  • Michigan Quality Improvement Consortium. Outpatient management of uncomplicated deep venous thrombosis. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Aug. 1 p.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Michigan Quality Improvement Consortium. Outpatient management of uncomplicated deep vein thrombosis. Southfield (MI): Michigan Quality Improvement Consortium; 2005 Aug. 1 p.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • February 28, 2008, Heparin Sodium Injection: The U.S. Food and Drug Administration (FDA) informed the public that Baxter Healthcare Corporation has voluntarily recalled all of their multi-dose and single-use vials of heparin sodium for injection and their heparin lock flush solutions. Alternate heparin manufacturers are expected to be able to increase heparin production sufficiently to supply the U.S. market. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.
  • August 16, 2007, Coumadin (Warfarin): Updates to the labeling for Coumadin to include pharmacogenomics information to explain that people's genetic makeup may influence how they respond to the drug.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The level of evidence grades (A-D) are provided for the most significant recommendations and are defined at the end of the "Major Recommendations" field.

Initial Assessment

  • Perform initial comprehensive history and physical examination; consider conditions predisposing to deep vein thrombosis (DVT).
  • Assess risk factors and contraindications to outpatient anticoagulation therapy. (See "Contraindications" field in this summary.)
  • Assess patient/caregiver ability and compliance for outpatient therapy and need for homecare resources

Pharmacologic Interventions

  • Outpatient therapy is preferred if no contraindications (see "Contraindications" field in this summary)
  • Begin warfarin after 1st dose of low molecular weight heparin (LMWH) [A]; on same day, titrate to International normalized ratio (INR) range of 2.0 to 3.0.
  • Continue LMWH until INR range 2.0 to 3.0 for 2 consecutive days (usually LMWH 5 to 7 days) [A].
  • Maintain warfarin therapy at least 3 months in therapeutic INR range [A], longer if risk of recurrence.
  • Ask about any changes in diet, medications, and compliance before any dosage adjustment.

Testing/Monitoring

  • Obtain baseline lab values: activated partial thromboplastin time (aPTT), prothrombin time (PT)/INR, complete blood count (CBC) with platelet count. Consider platelet count 3 to 5 days into anticoagulation therapy.
  • Monitor warfarin therapy using INR; no lab monitoring required for LMWH unless special circumstances such as renal insufficiency or extremes of body weight.
  • Frequent INR monitoring is necessary at the onset of therapy (e.g., at least 2 checks in the first week of therapy); then at least 2 to 3 times per week for the next 1 to 2 weeks. When stable, monitor every 4 to 8 weeks.
  • Maintain an Anticoagulant Monitoring Log (or dose adjustment system) for each patient treated with warfarin.
  • Monitor common bleeding sites: gums, nose, gastrointestinal, genitourinary, and skin.
  • Monitor for signs/symptoms of pulmonary embolism, risk factors, and side effects.
  • Management through a specialized program for anticoagulation monitoring, if available.

Patient Education

  • Inform patient/caregiver of the reasons for and benefits of therapy, potential side effects, importance of follow-up monitoring, warfarin dosage adjustment, compliance, dietary recommendations (i.e., a diet that is constant in vitamin K), the potential for drug interactions, safety precautions, and recognizing internal bleeding.
  • Instruct patient/caregiver on symptoms of pulmonary embolism, extension of DVT, and self-injection of LMWH.
  • The patient should be encouraged to be ambulatory after an appropriate weight-based dose of LMWH [D].
  • Compression stocking should be used routinely to prevent postthrombotic syndrome [A], beginning within 1 month of diagnosis of proximal DVT and continuing for a minimum of 1 year.

Definitions:

Levels of Evidence for the Most Significant Recommendations

  1. Randomized controlled trials
  2. Controlled trials, no randomization
  3. Observational studies
  4. Opinion of expert panel

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence is provided for the most significant recommendations (See "Major Recommendations" field).

This guideline is based on several sources, including: Management of Venous Thromboembolism: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2007;146:204-10.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Michigan Quality Improvement Consortium. Outpatient management of uncomplicated deep venous thrombosis. Southfield (MI): Michigan Quality Improvement Consortium; 2007 Aug. 1 p.

ADAPTATION

This guideline is based on several sources, including: Management of Venous Thromboembolism: A Clinical Practice Guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2007;146:204-10.

DATE RELEASED

2003 Aug (revised 2007 Aug)

GUIDELINE DEVELOPER(S)

Michigan Quality Improvement Consortium - Professional Association

SOURCE(S) OF FUNDING

Michigan Quality Improvement Consortium

GUIDELINE COMMITTEE

Michigan Quality Improvement Consortium Medical Director's Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Physician representatives from participating Michigan Quality Improvement Consortium health plans, Michigan State Medical Society, Michigan Osteopathic Association, Michigan Association of Health Plans, Michigan Department of Community Health and Michigan Peer Review Organization

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Standard disclosure is requested from all individuals participating in the Michigan Quality Improvement Consortium (MQIC) guideline development process, including those parties who are solicited for guideline feedback (e.g. health plans, medical specialty societies). Additionally, members of the MQIC Medical Directors' Committee are asked to disclose all commercial relationships.

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Michigan Quality Improvement Consortium. Outpatient management of uncomplicated deep vein thrombosis. Southfield (MI): Michigan Quality Improvement Consortium; 2005 Aug. 1 p.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on April 14, 2004. The information was verified by the guideline developer on July 27, 2004. This NGC summary was updated by ECRI on November 28, 2005. The updated information was verified by the guideline developer on December 19, 2005. This summary was updated by ECRI on March 6, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin sodium). This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin). This NGC summary was updated by ECRI Institute on March 5, 2008. The updated information was verified by the guideline developer on March 12, 2008.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which may be reproduced with the citation developed by the Michigan Quality Improvement Consortium.

DISCLAIMER

NGC DISCLAIMER

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Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
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