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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:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Genoox, Inc., and has financial interest in The ObG Project, Inc.

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 Feb 22 2019, 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). 

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