N/A
N=66
SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
Postpartum Anemia Nos
Bottom Line
View on ClinicalTrials.gov: NCT03419780 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Total Number of Units Transfused — 1.2; 2.1 units of blood — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood Transfusion (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Number of Units Transfused |
1.2; 2.1 | <0.001 sig |
| SECONDARY Length of Stay |
3.1; 3.4 | 0.79 |
| SECONDARY Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum |
16; 15 | 0.89 |
| SECONDARY Rate of Depression |
4; 5.5 | 0.34 |
| SECONDARY Rate of Fatigue |
44; 53 | 0.13 |
| SECONDARY Maternal Attachment Inventory Scores |
104; 104 | 0.55 |
| SECONDARY Infection Rate |
2; 1 | 1.00 |
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.
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 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 130 bpm, BP < 80/40
Data sourced from ClinicalTrials.gov (NCT03419780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.