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

Postpartum Anemia Nos Clinical Trial

— SMaRTBlood  

Official title:

Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419780
• Other study ID #: 829141
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Postpartum Anemia Nos

Intervention

Biological:
• Blood Transfusion
Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of Stay	To determine if there is a difference between single-unit and multiple-unit transfusion protocols in length of stay in days	From randomization until discharge from admission for delivery, an average of 2-3 days
Secondary	Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum	To determine if there is a difference between single-unit and multiple-unit transfusion protocols in exclusive breastfeeding rates at 4-9 weeks postpartum.	At 4-9 weeks after randomization
Secondary	Rate of Depression	• 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.	4-9 weeks after randomization
Secondary	Rate of Fatigue	• 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.	4-9 weeks after randomization
Secondary	Maternal Attachment Inventory Scores	• 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.	4-9 weeks after randomization
Secondary	Infection Rate	Development of any deep or superficial infection	From randomization until 4-9 week postpartum visit