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Guideline Summary
Guideline Title
Evidence-based patient safety advisory: blood dyscrasias.
Bibliographic Source(s)
Haeck PC, Swanson JA, Schechter LS, Hall-Findlay EJ, McDevitt NB, Smotrich GA, Reisman NR, Glasberg SB, ASPS Patient Safety Committee. Evidence-based patient safety advisory: blood dyscrasias. Plast Reconstr Surg. 2009 Oct;124(4 Suppl):82S-95S. [100 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

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.

  • November 6, 2013 – Low Molecular Weight Heparins External Web Site Policy: The U.S. Food and Drug Administration (FDA) is recommending that health care professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications for some time interval after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures. These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox and generic enoxaparin products and similar products.

Scope

Disease/Condition(s)
  • Blood dyscrasias, including von Willebrand disease, hemophilia, thrombocytopenia, and hypercoagulation
  • Conditions requiring plastic or reconstructive surgery
  • Bleeding and thrombotic complications of surgery
Guideline Category
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Anesthesiology
Hematology
Plastic Surgery
Surgery
Intended Users
Advanced Practice Nurses
Health Care Providers
Physician Assistants
Physicians
Guideline Objective(s)

To provide an overview of the perioperative steps that should be completed to ensure appropriate care for patients with blood disorders

Target Population

Patients with blood disorders who are undergoing or considering plastic or reconstructive surgery

Interventions and Practices Considered

Risk Assessment/Evaluation

Medical history:

  • Personal and family history of recurrent bleeding, bruising, or thrombosis, or menorrhagia, pregnancy complications in women
  • History of previous excessive posttraumatic or postsurgical bleeding
  • Use of antithrombotic drugs and other drugs/supplements that may affect coagulation

Management/Prevention/Treatment

  1. Preoperative coagulation testing as indicated
    • First-line clotting tests (activated partial thromboplastin time, prothrombin time)
  2. Perioperative management
    • Management of von Willebrand disease (vWD)
      • Determination of type of vWD
      • Desmopressin
      • Replacement factors, vWF/VIII plasma derived concentrates
      • Adjunctive agents (antifibrinolytics, topical thrombin, fibrin)
      • Evaluation of patient's response to therapy before surgery
      • Additional tests for inhibitors
    • Management of hemophilia A
      • Desmopressin
      • Replacement factors VIII (hemophilia A), IX (hemophilia B)
      • Adjunctive agents (antifibrinolytics, topical thrombin, fibrin)
      • Evaluation of patient's response to therapy before surgery
      • Additional tests for inhibitors
    • Management of patients with inhibitors
      • Replacement factors, recombinant or plasma derived (factor VIII, factor IX, factor VIIa, activated prothrombin complex concentrates)
      • Adjunctive agents (antifibrinolytics, topical thrombin, fibrin)
      • Evaluation of patient's response to therapy before surgery
    • Management of thrombocytopenias
      • Increase platelet count preoperatively
      • Corticosteroids
      • Immunoglobulin G
      • Vinca alkaloids
      • Platelet concentrate, red blood cells, fresh frozen plasma, plasmapheresis
    • Management of hypercoagulable (thrombotic) states
      • Prophylactic anticoagulants (heparin, warfarin, aspirin)
      • Postoperative graduated compression stockings, intermittent pneumatic compression devices, and early mobilization
Major Outcomes Considered
  • Hemorrhage
  • Venous thromboembolism (VTE)
  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

PubMed and the Cochrane Library were searched. The search terms used were: blood dyscrasia, blood disorder, blood disease, hypercoagulable, hypocoagulable, hemorrhagic, thrombotic, patient selection, preoperative assessment, physical examination, medical history, risk factors, diagnosis, von Willebrand disease, hemophilia, inhibitors, thrombocytopenia, venous thromboembolism (VTE), Factor V Leiden, treatment, prophylaxis, replacement factors, anticoagulants, desmopressin. No limits were set on publication dates in the searches. The searches included all types of published articles. However, articles that were critically appraised and rated for level of evidence were limited to systematic reviews, meta-analyses, randomized controlled trials (RCTs), clinical trials, comparative studies, case series and case reports.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Evidence Rating Scale for Studies Reviewed

Level of Evidence Qualifying Studies
I High-quality, multi-centered or single-centered, randomized controlled trial with adequate power; or a systematic review of these studies
II Lesser-quality, randomized controlled trial; prospective cohort study; or a systematic review of these studies
III Retrospective comparative study; case-control study; or a systematic review of these studies
IV Case series
V Expert opinion; case report or clinical example; or evidence based on physiology, bench research, or "first principles"
Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence

The supporting literature was critically appraised for study quality according to criteria referenced in key publications on evidence-based medicine. Depending on study design and quality, each reference was assigned a corresponding level of evidence (I through V) with the American Society of Plastic Surgeons (ASPS) Evidence Rating Scales, and the evidence was synthesized into practice recommendations. (see "Rating Scheme for the Strength of the Evidence")

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations
Grade Descriptor Qualifying Evidence Implications for Practice
A Strong Recommendation Level I evidence or consistent findings from multiple studies of levels II, III, or IV Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
B Recommendation Levels II, III, or IV evidence and findings are generally consistent Generally, clinicians should follow a recommendation but should remain alert to new information and sensitive to patient preference.
C Option Levels II, III, or IV evidence, but findings are inconsistent Clinicians should be flexible in their decision-making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.
D Option Level V; little or no systematic empirical evidence Clinicians should consider all options in their decision-making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.
Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
Internal Peer Review
Description of Method of Guideline Validation

The guideline was approved by the American Society of Plastic Surgeons Executive Committee on January 10, 2009.

Recommendations

Major Recommendations

Definitions for the levels of evidence (I–V) and the grades of the recommendations (A–D) are provided at the end of the "Major Recommendations" field.

Recommendations Supporting Evidence Grade
Patient Selection

Medical history (see Appendix B in the original guideline document for suggested questions for screening persons for a bleeding disorder)

It is recommended that the medical history include questions about:

  • Personal and family history of recurrent bleeding, bruising, or thrombosis
  • In women, a history of menorrhagia and/or pregnancy complications
  • Previous excessive posttraumatic or postsurgical bleeding
  • Use of antithrombotic drugs and other drugs/supplements that may affect coagulation (i.e., herbal remedies, hormone replacement therapy [HRT], oral contraceptives).

Chee et al., 2008; Kocher et al., 2007; Sottilotta et al., 2006; Jauniaux et al., 2006; Shaw & Rogers, 2005; Drews et al., 2002; Dilley et al., 2001; Kadir et al., 1998; Nichols, 2007; Wu et al., 2006

B
Preoperative Testing
  • If bleeding and thrombosis history is negative, preoperative coagulation testing is not recommended.
  • If bleeding and thrombosis history is positive or there is a clear clinical indication (e.g., liver disease), preoperative coagulation testing is recommended.
  • For patients requiring coagulation tests, first-line clotting tests may include activated partial thromboplastin time and prothrombin time. Bleeding time may or may not be helpful, depending on severity of blood disorder.

Chee et al., 2008; Nichols, 2007; Wu et al., 2006

B
Perioperative Management

Hypocoagulable (Hemorrhagic) States

von Willebrand Disease (vWD)

Determine type of vWD: type 1, type 2 (A, B, M, or N), or type 3.

Nichols, 2007; Federici, 2004; Castaman et al., 2008

B

Consider desmopressin as first approach to bleeding prophylaxis (most type 1; some type 2 patients; type 3 patients do not respond to desmopressin).

Nichols, 2007; Macksey & White, 2007; Koscielny et al., 2004; Federici, 2004; Association of Hemophilia Clinic Directors of Canada, 1999; Castaman et al., 2008; Michiels et al., 2007

B

For patients who do not respond to desmopressin (most type 2 and all type 3), consider replacement factors, vWF/VIII plasma derived concentrates.

Nichols, 2007; Lethagen et al., 2007; Michiels et al., 2004; Franchini et al., 2003; Koscielny et al., 2004; Association of Hemophilia Clinic Directors of Canada, 1999; Rivard et al., 2008; Michiels et al., 2007; Borel-Derlon et al., 2007; Federici et al., 2007; Shortt et al., 2007; Gill et al., 2003; Lillicrap et al., 2002; Mannucci et al., 2002; Lubetsky et al., 1999; Dobrkovska, Krzensk, & Chediak, 1998

B

If patients have an inadequate response to factor concentrates, additional tests should be considered to test for inhibitors.

Nichols, 2007; Association of Hemophilia Clinic Directors of Canada, 1999

B

Adjunctive agents (e.g., antifibrinolytics, topical thrombin or fibrin) can be considered, as needed.

Nichols, 2007; Filho et al., 2006; Koscielny et al., 2004; Association of Hemophilia Clinic Directors of Canada, 1999; Federici et al., 2000

D

Before surgery, the patient's response to therapies should be evaluated to ensure adequate hemostasis

Nichols, 2007; Federici, 2004; Association of Hemophilia Clinic Directors of Canada, 1999; Castaman et al., 2008

B

Hemophilia

For patients with hemophilia A, consider desmopressin as first approach to bleeding prophylaxis (desmopressin is not effective in patients with hemophilia B).

National Hemophilia Foundation, 2007; Association of Hemophilia Clinic Directors of Canada, 1999

D

For patients who do not respond to desmopressin, consider plasma-derived or recombinant replacement factor concentrates, factor VIII (hemophilia A), and factor IX (hemophilia B).

Petros et al., 2007; Kuwahara et al., 2006; Cermelj et al., 2004; Knott, Khariwala, & Minarchek, 2005; Sennett & de Alarcon, 2004; Caldicott et al., 2004; Murugan et al., 2006; Delgado & Sanders, 2004; National Hemophilia Foundation, 2007; Association of Hemophilia Clinic Directors of Canada, 1999; Celiker et al., 2004; Sarris et al., 2007; Redwine & Bold, 2007

B

If patients have an inadequate response to factor concentrates, additional tests should be considered to test for inhibitors.

Hay et al., 2006; National Hemophilia Foundation, 2007; Association of Hemophilia Clinic Directors of Canada, 1999

B

Adjunctive agents (e.g., antifibrinolytics, topical thrombin or fibrin) can be considered, as needed.

Hay et al., 2006; Stumpf, Eberhardt, & Kurth, 2007; National Hemophilia Foundation, 2007; Sarris et al., 2007; Coetzee, 2007

D

Before surgery, the patient's response to therapies should be evaluated to ensure adequate hemostasis.

National Hemophilia Foundation, 2007; Association of Hemophilia Clinic Directors of Canada, 1999

D

Patients with Inhibitors

For patients with low-responding inhibitors, consider high doses of recombinant factor concentrates, or plasma derived concentrates if recombinant forms are unavailable.

Hay et al., 2006; Association of Hemophilia Clinic Directors of Canada, 1999

D

For high-responding inhibitors, either low or high titer, consider recombinant factor VIII or factor IX, or bypass therapies, activated prothrombin complex concentrates (aPCC) (e.g., factor VIII inhibitor by passing activity [FEIBA]) or recombinant factor VIIa.

Shaw & Rogers, 2005; Rodriguez-Merchan et al., 2003; Hay et al., 2006; Dimichele & Negrier, 2006; Goudemand, Tagariello, & Lopaciuk, 2004; Slaoui et al., 2004; Stine, Shrum, & Becton, 2007; Janic et al., 2007; Pekcelen et al., 2005; Shu, Moore, & Moore, 2004; Stumpf, Eberhardt, & Kurth, 2007; Association of Hemophilia Clinic Directors of Canada, 1999; Coetzee, 2007; Pruthi et al., 2007; Smith et al., 2001; Santagostino et al., 2001; Redwine & Bold, 2007; Astermark et al., 2007

B

Adjunctive agents (e.g., antifibrinolytics, topical thrombin or fibrin) can be considered, as needed.

Hay et al., 2006; Pekcelen et al., 2005; Stumpf, Eberhardt, & Kurth, 2007; Association of Hemophilia Clinic Directors of Canada, 1999

D

Before surgery, the patient's response to therapies should be evaluated to ensure adequate hemostasis.

Hay et al., 2006; Association of Hemophilia Clinic Directors of Canada, 1999

D
Thrombocytopenias

Increase platelet count preoperatively.

Felbinger et al., 2007

D

Consider the use of corticosteroids or immunoglobulin G (IgG).

Moeller-Bertram, Kuczkowski, & Benumof, 2004

D

Consider vinca alkaloids for patients who do not respond to corticosteroids.

Szczepanik et al., 2007

D

Consider platelet concentrate, red blood cells, fresh frozen plasma, and plasmapheresis.

Felbinger et al., 2007; Martini et al., 2007; Dias Perera et al., 2007

D
Hypercoagulable (Thrombotic) States

Presence of thrombophilia disorders is considered a significant risk for the development of venous thromboembolism (VTE).

Shaw & Rogers, 2005; Wu et al., 2006; Salvati et al., 2005; Ruggeri et al., 2008; de la Cruz, Berenguer, & de la Plaza, 2005

B

It is unclear whether presence of thrombophilia increases risk for recurrent VTE.

Martinelli et al., 2004; Baglin et al., 2003

C

Prophylactic anticoagulants (e.g., heparin, warfarin, aspirin) should be considered before, during, and after surgery medications; should be adjusted as needed to prevent hemorrhage.

Petros et al., 2007; Stammers et al., 2005; Pivalizza, 2003; Sharathkumar & Stanley 2008; Agaba et al., 2006

D

Postoperative graduated compression stockings, intermittent pneumatic compression devices, and early mobilization are recommended after surgery to prevent thrombosis.

Salvati et al., 2005; Agaba et al., 2006; Hosoi et al., 2004

D

Note: For more information on DVT/PE prophylaxis, consult the National Guideline Clearinghouse (NGC) summary of the ASPS guideline, Evidence-Based Patient Safety Advisory: Patient Selection and Procedures in Ambulatory Surgery.

Definitions:

Evidence Rating Scale for Studies Reviewed

Level of Evidence Qualifying Studies
I High-quality, multi-centered or single-centered, randomized controlled trial with adequate power; or a systematic review of these studies
II Lesser-quality, randomized controlled trial; prospective cohort study; or a systematic review of these studies
III Retrospective comparative study; case-control study; or a systematic review of these studies
IV Case series
V Expert opinion; case report or clinical example; or evidence based on physiology, bench research, or "first principles"

Scale for Grading Recommendations

Grade Descriptor Qualifying Evidence Implications for Practice
A Strong Recommendation Level I evidence or consistent findings from multiple studies of levels II, III, or IV Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
B Recommendation Levels II, III, or IV evidence and findings are generally consistent Generally, clinicians should follow a recommendation but should remain alert to new information and sensitive to patient preference.
C Option Levels II, III, or IV evidence, but findings are inconsistent Clinicians should be flexible in their decision-making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.
D Option Level V; little or no systematic empirical evidence Clinicians should consider all options in their decision-making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.
Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

References Supporting the Recommendations
Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate care for patients with blood disorders to prevent perioperative and postoperative complications

Potential Harms

Not stated

Qualifying Statements

Qualifying Statements
  • Practice advisories are strategies for patient management, developed to assist physicians in clinical decision-making. This practice advisory, based on a thorough evaluation of the present scientific literature and relevant clinical experience, describes a range of generally acceptable approaches to diagnosis, management, or prevention of specific diseases or conditions. This practice advisory attempts to define principles of practice that should generally meet the needs of most patients in most circumstances. However, this practice advisory should not be construed as a rule, nor should it be deemed inclusive of all proper methods of care or exclusive of other methods of care reasonably directed at obtaining the appropriate results. It is anticipated that it will be necessary to approach some patients' needs in different ways. The ultimate judgment regarding the care of a particular patient must be made by the physician in light of all the circumstances presented by the patient, the diagnostic and treatment options available, and available resources.
  • This practice advisory is not intended to define or serve as the standard of medical care. Standards of medical care are determined on the basis of all the facts or circumstances involved in an individual case and are subject to change as scientific knowledge and technology advance, and as practice patterns evolve. This practice advisory reflects the state of knowledge current at the time of publication. Given the inevitable changes in the state of scientific information and technology, periodic review and revision will be necessary.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Living with Illness
Staying Healthy
IOM Domain
Effectiveness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Haeck PC, Swanson JA, Schechter LS, Hall-Findlay EJ, McDevitt NB, Smotrich GA, Reisman NR, Glasberg SB, ASPS Patient Safety Committee. Evidence-based patient safety advisory: blood dyscrasias. Plast Reconstr Surg. 2009 Oct;124(4 Suppl):82S-95S. [100 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Oct
Guideline Developer(s)
American Society of Plastic Surgeons - Medical Specialty Society
Source(s) of Funding

American Society of Plastic Surgeons

Guideline Committee

American Society of Plastic Surgeons Patient Safety Committee

Composition of Group That Authored the Guideline

Committee Members: Phillip C. Haeck, M.D. (Chairman); Stephen B. Baker, M.D., D.D.S., Georgetown University Hospital, Washington, D.C.; Charles W. Bailey, Jr., M.D., J.D., Austin, Texas; C. Bob Basu, M.D., M.P.H., Center for Advanced Breast Restoration and Basu Plastic Surgery, Houston, Texas; Lynn A. Damitz, M.D., University of North Carolina, Chapel Hill, North Carolina; Felmont F. Eaves, III, M.D., Charlotte Plastic Surgery, Charlotte, North Carolina; Paul D. Faringer, M.D., Kaiser Permanente, Honolulu, Hawaii; Scot Bradley Glasberg, M.D., Lenox Hill Hospital and Manhattan Eye Ear and Throat Hospital, New York, New York; Lawrence S. Glassman, M.D., Nyack Hospital, Nyack, New York; Karol A. Gutowski, M.D., North Shore University Health System and University of Chicago, Evanston, Illinois; Elizabeth J. Hall-Findlay, M.D., private practice, Banff, Alberta, Canada; Ronald E. Iverson, M.D., Stanford University Medical School, Palo Alto, California; Linda J. Leffel, M.D., Bend, Oregon; Dennis J. Lynch, M.D., retired, Scott and White Healthcare, Texas A&M University, Temple, Texas; Noel B. McDevitt, M.D., Pinehurst Surgical, Pinehurst, North Carolina; Michael F. McGuire, M.D., David Geffen UCLA School of Medicine, Los Angeles, California; Patrick J. O'Neill, M.D., Medical University of South Carolina, Charleston, South Carolina; Neal R. Reisman, M.D., J.D., St. Luke's Episcopal Hospital and Baylor College of Medicine, Houston, Texas; Gary F. Rogers, M.D., Children's Hospital Boston, Boston, Massachusetts; Loren S. Schechter, M.D., Morton Grove, Illinois; Maria Siemionow, M.D., Ph.D., D.Sc., Cleveland Clinic, Cleveland, Ohio; Robert Singer, M.D., University of California, San Diego, La Jolla, California; Gary A. Smotrich, M.D., Lawrenceville Plastic Surgery, Lawrenceville, New Jersey; Rebecca S. Twersky, M.D., M.P.H., SUNY Downstate Medical Center, Brooklyn, New York; Amy G. Wandel, M.D., Mercy Medical Group, Sacramento, California; Ronald H. Wender, M.D., Cedars-Sinai Medical Center, Los Angeles, California; and James A. Yates, M.D., Grandview Surgery Center, Vista Surgery Center, Plastic Surgery Center, and Holy Spirit Hospital, Camp Hill, Pennsylvania

Financial Disclosures/Conflicts of Interest

The authors have no financial interests related to this article.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Society of Plastic Surgeons Web site External Web Site Policy.

Print copies: Available from the American Society of Plastic Surgeons, 444 East Algonquin Road, Arlington Heights, IL 60005-4664

Availability of Companion Documents

None available

Patient Resources

None available

NGC Status

This NGC summary was completed by ECRI Institute on June 10, 2010. The information was verified by the guideline developer on August 31, 2010. This summary was updated by ECRI Institute on March 10, 2014 following the U.S. Food and Drug Administration advisory on Low Molecular Weight Heparins.

Copyright Statement

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Copyright ©2009 by the American Society of Plastic Surgeons

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

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