SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia

NCT03419780 | Completed Results

• 1 other identifier: 829141
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Anemia Nos

Outcome Measures

Primary Outcomes (1)

• Total Number of Units Transfused

  To determine if there is a difference between single-unit and multiple-unit transfusion protocols in total number of units transfused

  From randomization until discharge from admission for delivery, an average of 2-3 days

Secondary Outcomes (6)

• Length of Stay

  From randomization until discharge from admission for delivery, an average of 2-3 days

• Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum

  At 4-9 weeks after randomization

• Rate of Depression

  4-9 weeks after randomization

• Rate of Fatigue

  4-9 weeks after randomization

• Maternal Attachment Inventory Scores

  4-9 weeks after randomization

Study Arms (2)

Single-Unit Blood Transfusion Protocol

ACTIVE COMPARATOR

In this arm, patients receive a 1 unit pRBC transfusion with the plan for post-transfusion blood count at 4-6 hours post-transfusion and clinical reassessment.

Biological: Blood Transfusion

Multiple-Unit Blood Transfusion Protocol

ACTIVE COMPARATOR

In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.

Biological: Blood Transfusion

Interventions

Blood Transfusion BIOLOGICAL

Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.

Multiple-Unit Blood Transfusion Protocol; Single-Unit Blood Transfusion Protocol

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is determined by delivery of a fetus.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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.

  PMID: 34932836 DERIVED

• 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.

  PMID: 32652065 DERIVED

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Results Point of Contact

• Title: Dr Rebecca Hamm
• Organization: University of Pennsylvania

rebecca.feldmanhamm@pennmedicine.upenn.edu

215-662-6913

Study Officials

• Sindhu K Srinivas, MD MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 5, 2018
• Study Start: March 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: November 4, 2020
• Results First Posted: November 4, 2020

Record last verified: 2020-11

Locations

US (1)