Can a Single-unit Blood Transfusion Protocol in Obstetrics Reduce Total Number of Units Transfused? A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Total Number of Units Transfused
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •hemoglobinopathies
- •patients with an ejection fraction <35%
- •Hb <5 g/dL
- •HR > 130 bpm, BP < 80/40
结局指标
主要结局
Total Number of Units Transfused
时间窗: 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
次要结局
- Rate of Depression(4-9 weeks after randomization)
- Rate of Fatigue(4-9 weeks after randomization)
- Maternal Attachment Inventory Scores(4-9 weeks after randomization)
- Length of Stay(From randomization until discharge from admission for delivery, an average of 2-3 days)
- Number of Participants Exclusively Breastfeeding at 4-9 Weeks Postpartum(At 4-9 weeks after randomization)
- Infection Rate(From randomization until 4-9 week postpartum visit)
