Clinical trial NCT03419780: SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
Official title: Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Anemia Nos
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a paucity of data on management of non-acute postpartum anemia. Although blood transfusions were historically initiated with 2 units, the most recent recommendation from the American Association of Blood Banks is to begin with 1 unit. As no randomized controlled trials have been performed in obstetrics, the investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single- versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity.

Detailed description: Postpartum hemorrhage (PPH), which accounts for 30% of all direct maternal deaths, is the single most important cause of maternal morbidity and mortality across the globe and is a focus of attention of national organizations such as the Council for Patient Safety in Women's Health in recent years. Yet, there remains a paucity of data on the appropriate management of non-acute postpartum anemia.

It is common practice in obstetrics to offer a transfusion of packed red blood cells (pRBCs) to women with a hemoglobin (Hb) value less than 7 g/dL (hematocrit less than 20%) and to symptomatic women with even higher hemoglobin levels. Although transfusions were historically initiated with 2 units of pRBCs, the most recent recommendation from the American Association of Blood Banks (AABB) for a stable patient is to begin with 1 unit and reassess. However, while surgical data has successfully demonstrated that liberal blood transfusion increases morbidity and mortality in comparison to restricted transfusion, no randomized controlled trials have been performed in obstetrics to demonstrate superiority of a single-unit transfusion protocol.

The investigators propose a randomized, controlled trial in non-acute postpartum anemia comparing single-unit versus multiple-unit transfusion by total numbers of units transfused and maternal morbidity at the University of Pennsylvania with the hypothesis that single-unit transfusions can reduce the number of units transfused without increasing maternal morbidity.

Eligibility criteria: Inclusion Criteria:

* Women over 18
* Willing and stable to give consent
* \> 6 hours postpartum from any mode of delivery
* Determined by their physician to require blood transfusion either by:

  * Hb \<7g/dL OR
  * \>7g/dL with any sign or symptom of anemia such as fatigue, dizziness, tachycardia, or hypotension
* Agreed to accept blood transfusion
* No contraindications to blood transfusion

Exclusion Criteria:

* hemoglobinopathies
* patients with an ejection fraction \<35%
* Hb \<5 g/dL
* HR \> 130 bpm, BP \< 80/40

Primary outcomes:
measure: Total Number of Units Transfused
timeFrame: From randomization until discharge from admission for delivery, an average of 2-3 days
Secondary outcomes:
measure: Length of Stay
timeFrame: From randomization until discharge from admission for delivery, an average of 2-3 days
measure: Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum
timeFrame: At 4-9 weeks after randomization
measure: Rate of Depression
timeFrame: 4-9 weeks after randomization
measure: Rate of Fatigue
timeFrame: 4-9 weeks after randomization
measure: Maternal Attachment Inventory Scores
timeFrame: 4-9 weeks after randomization
measure: Infection Rate
timeFrame: From randomization until 4-9 week postpartum visit
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sindhu K Srinivas, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
citation: Hamm RF, Perelman S, Wang EY, Levine LD, Srinivas SK. Single-unit vs multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized controlled trial. Am J Obstet Gynecol. 2021 Jan;224(1):84.e1-84.e7. doi: 10.1016/j.ajog.2020.07.007. Epub 2020 Jul 9.