NCT03419780: SMaRTBlood

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

Completed NA Results posted Last updated 4 November 2020

What this trial tests

NA trial testing Blood Transfusion in Postpartum Anemia Nos in 66 participants. Completed in 1 June 2020.

Timeline

1 March 2018

Primary endpoint
1 June 2020

1 June 2020

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	1 March 2018
Primary completion	1 June 2020
Estimated completion	1 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Blood Transfusion — full drug profile →

Conditions studied

• Postpartum Anemia Nos — all drugs for Postpartum Anemia Nos →

Sponsor

University of Pennsylvania

Who can join

18 and older, female only, with Postpartum Anemia Nos. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Units Transfused Primary · From randomization until discharge from admission for delivery, an average of 2-3 days

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

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	1.2	± 0.5
Multiple-Unit Blood Transfusion Protocol	2.1	± 0.4

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

To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	3.1	2.5 – 3.8
Multiple-Unit Blood Transfusion Protocol	3.4	2.4 – 4.1

Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum Secondary · At 4-9 weeks after randomization

To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum.

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	16
Multiple-Unit Blood Transfusion Protocol	15

Rate of Depression Secondary · 4-9 weeks after randomization

• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Edinburgh Postnatal Depression Scale score at 4-9 weeks postpartum. EPDS scores range from 0-30, with higher scores (particularly above 10) are indicative of depression.

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	4	1 – 11
Multiple-Unit Blood Transfusion Protocol	5.5	2 – 8

Rate of Fatigue Secondary · 4-9 weeks after randomization

• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Multidimensional Fatigue Inventory scores at 4-9 weeks postpartum. This score ranges from 0-140 with higher scores indicating worse fatigue.

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	44	34 – 55
Multiple-Unit Blood Transfusion Protocol	53	38 – 70

Maternal Attachment Inventory Scores Secondary · 4-9 weeks after randomization

• To determine if there is a difference between single-unit and multiple-unit transfusion protocols in Maternal Attachment Inventory scores at 4-9 weeks postpartum. The possible range of scores is 26-104. Higher scores indicate higher maternal attachment to the infant.

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	104	102 – 104
Multiple-Unit Blood Transfusion Protocol	104	102 – 104

Infection Rate Secondary · From randomization until 4-9 week postpartum visit

Development of any deep or superficial infection

Group	Value	95% CI
Single-Unit Blood Transfusion Protocol	2
Multiple-Unit Blood Transfusion Protocol	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Randomization until the time of the postpartum visit which occurred between 4 and 9 weeks after delivery.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Single-Unit Blood Transfusion Protocol

Serious: 0/33 (0%)

Deaths: 0/33

Multiple-Unit Blood Transfusion Protocol

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (1 terms — click to expand)

Reaction	System	Single-Unit Blood Transfus…	Multiple-Unit Blood Transf…
Unrelated transfer to the ICU	Pregnancy, puerperium and perinatal conditions	—	—

Data from ClinicalTrials.gov NCT03419780 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hemoglobin Change after Red Blood Cell Transfusion for Postpartum Anemia: Secondary Analysis of a Randomized, Controlled Trial.
   Rush M, Srinivas SK, Hamm RF. · · 2024 · cited 3× · PMID 36822207 · DOI 10.1055/s-0043-1763503