Blood Transfusion Risk After Early vs. Delayed Surgery in Hip Fracture Patients on Direct Oral Anticoagulants: A Natural Experiment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 7
- 主要终点
- Number of participants receiving a postoperative blood transfusion
研究概览
简要总结
This study looks at patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. In many hospitals, surgery for these patients is delayed because of concerns about bleeding, but waiting longer can also increase risks such as complications and longer hospital stays. The purpose of this study is to find out whether operating within 24 hours is as safe as delaying surgery beyond 24 hours. Specifically, the investigators want to know if early surgery does not lead to a higher need for blood transfusions compared to delayed surgery.
详细描述
Detailed Description Hip fractures are one of the most common reasons for hospital admission among older adults, and surgery is usually performed as quickly as possible because delays are linked to higher risks of complications, longer hospital stays, and even increased mortality. However, in patients who are taking direct oral anticoagulants (DOACs), surgeons often postpone surgery due to concerns about bleeding. While waiting allows time for the anticoagulant effect to diminish, it also exposes patients to the risks of surgical delay.
At present, there is no clear international consensus on the safest timing for surgery in this group of patients. Some hospitals routinely wait 24-48 hours, while other hospitals have a protocol that allows to operate within 24 hours based on expert-opinion. This variation in clinical practice across hospitals in the Netherlands creates a unique opportunity to study the question as a natural experiment.
This multicenter cohort study will compare outcomes between patients who undergo hip fracture surgery within 24 hours of emergency department presentation ("early surgery") and those who undergo surgery after 24 hours ("delayed surgery"). The primary focus is whether early surgery leads to a higher risk of requiring a blood transfusion after the operation. Secondary analyses will evaluate perioperative hemoglobin changes, postoperative complications (including infections, delirium, and thromboembolic events), hospital length of stay, mortality rates, and functional recovery at three months.
Data Collection and Quality This study relies on clinical data routinely documented in the electronic health record (EHR). No additional procedures or interventions are carried out. Before the start of the study, a standardized preparation phase was implemented across all participating hospitals to ensure that every variable required for analysis would be registered consistently and completely in the EHR.
To achieve this, variables that are frequently underreported were identified, including the timing and indication of the last DOAC dose, nutritional and frailty assessments, and reasons for surgical delay, and actively addressed them in advance. Posters and concise checklists were distributed to all relevant clinical teams (emergency medicine, anesthesiology, geriatrics, surgery, and nursing) to raise awareness and provide clear reminders. By embedding these prompts into daily clinical practice, a shared understanding among staff was established that these data points are critical for the study and must be documented accurately in the patient record.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolated hip fracture classified as AO/OTA 31A or 31B requiring surgical intervention.
- •Current DOAC use with the last dose taken ≤24 hours before emergency department (ED) presentation
排除标准
- •Pathologic or periprosthetic hip fractures.
- •Fracture sustained >24 hours before ED presentation.
- •Inter-hospital transfer.
- •Hematologic disorders (e.g., thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, leukemia).
- •Use of a non-EMA-approved DOAC (e.g., betrixaban).
结局指标
主要结局
Number of participants receiving a postoperative blood transfusion
时间窗: From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively)
Receiving one or more units of packed red blood cells in the postoperative period during hospitalization
次要结局
- Number of participants receiving a preoperative blood transfusion(From emergency department presentation until start of surgery (up to 7 days preoperatively))
- Number of packed red blood cells administered postoperatively(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of packed red blood cells administered preoperatively(From emergency department presentation until start of surgery (up to 7 days preoperatively))
- Surgical duration in minutes(During surgery/procedure)
- Intraoperative blood loss in milliliteres(During surgery)
- Number of participants requiring intraoperative use of tranexamic acid, fibrinogen or trombocytes(During surgery)
- Number of participants requiring a reoperation(From end of surgery until hospital discharge)
- Number of participants categorized by reason for reoperation(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with postoperative sciatic neuropraxia(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Postoperative hemoglobin(Measured within 24 hours postoperatively)
- Postoperative hematocrite(Measured within 24 hours postoperatively)
- Delta hemoglobin(Measured within 24 hours postoperatively)
- Bleeding index(Measured within 24 hours postoperatively)
- Time untill restart of DOAC(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a hemoglobin change greater than 2 mmol/L(Measured within 24 hours postoperatively)
- Number of participants with postoperative anemia(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with postoperative hematoma(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a pressure ulcer(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a myocardial infarction(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with arterial thrombosis(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of particiapants with a deep venous thrombosis(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a pulmonary embolism(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a delirium(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a pneumonia(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a superficial surgical wound infection(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a deep surgical wound infection(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with wound leakage(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Days of wound leakage(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with congestive heart failure(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with renal insufficiency(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with a urinary tract infection(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with an in hospital fall(From end of hip fracture surgery until hospital discharge (up to 30 days postoperatively))
- Number of participants with in-hospital mortality(From end of hip fracture surgery until hospital discharge (up to 120 days postoperatively))
- Number of participants with a 30-day mortality(30 days after hip fracture surgery)
- Hospital length of stay(Day of Emergency Department presentation until day of hospital discharge)
- Discharge destination(At the day of hospital discharge after hip facture surgery (up to 120 days postoperatively))
研究者
Tim Schiepers
Medical Doctor
St. Antonius Hospital