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

Not Applicable

Completed

• Conditions: Postpartum Anemia Nos
• Interventions: Biological: Blood Transfusion

• Registration Number: NCT03419780
• Lead Sponsor: University of Pennsylvania

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-03-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Results First Submitted: 2020-10-01
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-03
• Last Update Submitted: 2020-11-03
• Results First Posted: 2020-11-04
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 66

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple-Unit Blood Transfusion Protocol	Blood Transfusion	In this arm, patients receive 2 units of pRBCs, followed by 4-6 hour post-transfusion blood count and clinical reassessment.
Single-Unit Blood Transfusion Protocol	Blood Transfusion	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.

Primary Outcome Measures

Name	Time	Method
Total Number of Units Transfused	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

Secondary Outcome Measures

Name	Time	Method
Rate of Depression	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.
Rate of Fatigue	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.
Maternal Attachment Inventory Scores	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.
Length of Stay	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
Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum	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.
Infection Rate	From randomization until 4-9 week postpartum visit	Development of any deep or superficial infection

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States