SMaRT Blood: Single-unit Versus Multiple-unit Packed Red Blood Cell Transfusion in Non-acute Postpartum Anemia
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2019 |
| Start Date: | March 1, 2018 |
| End Date: | September 2022 |
| Contact: | Rebecca F Hamm, MD |
| Email: | rebecca.feldmanhamm@uphs.upenn.edu |
| Phone: | 2156622982 |
Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
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.
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.
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.
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.
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
We found this trial at
1
site
3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Principal Investigator: Sindhu K Srinivas, MD MSCE
Phone: 215-662-2982
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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