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临床试验/NCT07544017
NCT07544017尚未招募不适用

The Impact of Implementing a Hospital-wide Patient Blood Management (PBM) Program on Blood Product Utilization and Maternal Outcomes in All Obstetric Deliveries: a Retrospective Observational Study (2018-2025)

Corniche Hospital1 个研究点 分布在 1 个国家目标入组 44,000 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
44,000
试验地点
1
主要终点
Mean number of blood product units transfused per delivery

研究概览

简要总结

Obstetric anemia and hemorrhage are major causes of maternal morbidity and increased healthcare utilization. Although red blood cell (RBC) transfusion is commonly used, it is associated with higher rates of postpartum complications, including pneumonia, renal failure, and cardiac events (Kloka et al.).

Patient Blood Management (PBM) is an evidence-based approach that aims to optimize a patient's own blood and reduce avoidable transfusion through three pillars: treating anemia and iron deficiency, minimizing blood loss, and avoiding unnecessary transfusion. International guidelines support PBM in obstetrics, but data on comprehensive program implementation remain limited due to barriers such as resource constraints and the need for multidisciplinary coordination.

Aims , objectives and Hypotheses Primary Aim To assess the association between PBM implementation and blood product utilisation among all obstetric deliveries at Corniche Hospital between 2018 and 2025.

Primary Objective To estimate the change over time in the mean number of blood product units transfused per delivery (combined and by product type).

Primary Hypothesis Increasing PBM maturity over time, particularly following comprehensive PBM implementation in 2022, is associated with a significant reduction in mean blood product units transfused per delivery, after adjusting for changes in case-mix.

Secondary Objectives Secondary objectives include evaluating changes in transfusion-related practice and anemia outcomes, including proportion of deliveries receiving any transfusion; pretransfusion hemoglobin thresholds in non-actively bleeding patients (where definable); predelivery anemia prevalence (and iron therapy utilization where captured).

Maternal outcomes will be evaluated by reporting composite morbidity; postpartum hysterectomy; hospital length of stay; High Dependency unit (HDU)/ICU admission and length of stay; 28-day all-cause emergency readmissions; in-hospital mortality. Neonatal outcomes will not be included.

At Corniche Hospital, prior evaluation in cases of major obstetric hemorrhage showed that PBM reduced blood product use and improved hemoglobin recovery without increasing morbidity (Ansari et al.). This study extends the assessment to all deliveries from 2018-2025 to evaluate hospital-wide changes in transfusion practice and maternal outcomes as PBM implementation matured.

详细描述

Aims / Objectives / Hypotheses Primary Aim To assess the association between PBM implementation and blood product utilization among all obstetric deliveries at Corniche Hospital between 2018 and 2025.

Primary Objective To estimate the change over time in the mean number of blood product units transfused per delivery (combined and by product type).

Primary Hypothesis Increasing PBM maturity over time, particularly following comprehensive PBM implementation in 2022, is associated with a significant reduction in mean blood product units transfused per delivery, after adjusting for changes in case-mix.

Secondary Objectives Secondary objectives include evaluating changes in transfusion-related practice and anemia outcomes, including proportion of deliveries receiving any transfusion; pretransfusion hemoglobin thresholds in non-actively bleeding patients (where definable); predelivery anemia prevalence (and iron therapy utilization where captured).

Maternal outcomes will be evaluated by reporting composite morbidity; postpartum hysterectomy; hospital length of stay; HDU/ICU admission and length of stay; 28-day all-cause emergency readmissions; in-hospital mortality. Neonatal outcomes will not be included.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All women delivered at Corniche Hospital during the study period

排除标准

  • 未提供

研究组 & 干预措施

All patients delivered between 2018 and 2025

结局指标

主要结局

Mean number of blood product units transfused per delivery

时间窗: 2018 - 2025

measured combined units of RBC, FFP and platelet units measured per delivery

次要结局

  • Proportion of deliveries receiving any blood product (RBC/FFP/platelets)(2018-2025)
  • Mean pretransfusion Hb in non-actively bleeding patients (where definable)(2018-2025)
  • Predelivery anemia prevalence (define threshold consistent with local policy; e.g., Hb <11g/dL)(2018-2025)
  • Utilization of IV iron pre- and post-delivery (if available and reliable)(2018-2025)
  • Composite morbidity(2018-2025)
  • Postpartum hysterectomy (standalone)(2018-2025)
  • In-hospital mortality(2018-2025)
  • Hospital length of stay (LOS)(2018-2025)
  • HDU/ICU LOS (if available)(2018-2025)
  • 28-day all-cause emergency readmissions(2018-2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tarek Ansari

Head of Anesthesia department

Corniche Hospital

研究点 (1)

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