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Grand Rounds
CMECNE

Results of the SALVO Trial: Cell Salvage During Cesarean Section

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. State the reasoning behind undertaking this large randomized controlled trial on the use of cell salvage during cesarean section
2. Discuss the results of the SALVO trial

Estimated time to complete activity: 0.25 hours

Faculty:

Ashley Comfort, MD, FACOG is the Director of Medical Content, ObG Project.

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.

Faculty: Ashley Comfort, MD, has a financial interest in Pfizer and has no other conflicts of interest to disclose.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from Feb 22 2018 through Mar 1 2023, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Read Disclaimer & Fine Print

BACKGROUND AND PURPOSE:

  • Cell salvage collects, processes, and returns the woman’s own blood lost during surgery
  • Cell salvage during non-obstetric surgery can prevent blood transfusion
  • Limited data is available for the benefit of this technique during cesarean section
  • There is a concern for amniotic fluid embolism and red cell isoimmunization with cell salvage
  • Khan et al. (PLoS Med., 2017) sought to confirm if cell salvage can reduce the need for transfusion

METHODS:

  • Pragmatic randomized controlled trial
  • SALVO trial (cell SALVage in Obstetrics), including 26 UK obstetric units
  • Women undergoing cesarean section at risk of hemorrhage were randomized to either
    • Cell salvage
    • Current standard of care without salvage use
  • Multivariable models was used for an intention-to-treat analysis
  • Primary outcome
    • Rates of donor blood transfusion
  • Secondary outcome
    • Fetomaternal hemorrhage ≥2 ml in RhD-negative women with RhD-positive babies

RESULTS:

  • 3,028 women were randomized, with 2,990 women included in the analysis
    • 1498 in intervention group / 1492 in control group
  • Intervention group
    • Cell salvage deployed in 95.6%
    • 50.8% had salvaged blood returned (mean volume of returned blood was 259.9 ml)
    • 3.9% of the control group had cell salvage
  • Blood transfusion rate
    • 3.5% in the control group
    • 2.5% in the intervention group
    • Adjusted odds ratio [OR] 0.65 (95% CI, 0.42 to 1.01, p = 0.056)
    • Adjusted risk difference -1.03 (95% CI, -2.13 to 0.06)
  • Planned subgroup analysis: Comparing transfusion rates in emergency vs elective cesarean
    • Emergency cesarean: Transfusion rate was 4.6% in controls vs 3.0% in the intervention group among emergency cesareans (adjusted OR 0.58, 95% CI 0.34 to 0.99)
    • Elective cesarean: Transfusion rate was 2.2% in controls vs 1.8% (adjusted OR 0.83, 95% CI 0.38 to 1.83)
  • Fetomaternal hemorrhage
    • 25.6% in the intervention group vs 10.5% in the control group
      • Adjusted OR 5.63 (95% CI, 1.43 to 22.14; p = 0.013)
  • There were no cases of amniotic fluid embolism

CONCLUSION:

  • The use of cell salvage did not significantly reduce use of donor blood transfusion in all women undergoing cesarean section
    • Emergency cesarean sections have higher blood loss and transfusion is usually the mainstay of treatment to treat hemorrhage
    • The potential for benefit in this group merits confirmation through additional research
  • Cell salvage was associated with increased maternal exposure to fetal blood among RhD-negative mothers
    • Authors expressed caution in interpreting these results as there were large rates of missing data
    • Additional doses of anti-D following birth of an RhD-positive baby to an RhD-negative mother after cell salvage may be required

Learn More – Primary Sources:

Cell salvage and donor blood transfusion during cesarean section: A pragmatic, multicentre randomised controlled trial (SALVO). 

Take a post-test and get CME credits

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Computer System Requirements

OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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