The Impact of Bleeding on Delirium Outcomes in Older Patients With Hip Fractures: A Single-Blind, Randomized Controlled Trial - The IMPROVE-HIP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Number of Participants with Delirium
研究概览
简要总结
The goal of this clinical trial is to investigate whether early detection of bleeding and prompt blood transfusions can help prevent delirium in patients aged 75 and older who are admitted to the hospital with hip fractures. The main question the trial aims to answer is:
Do patients aged 75 and older with hip fractures benefit from earlier treatment of anemia (low blood count) to reduce the risk of delirium?
Researchers will compare early diagnosis and treatment of bleeding with standard care to determine if it helps lower the risk of developing delirium.
Participants will:
Undergo blood tests, have their vital signs monitored, and be screened for delirium three times a day for the first 48 hours after surgery.
Receive blood transfusions promptly if their hemoglobin levels fall below a specified threshold.
Attend a follow-up visit at 30 days to assess cognitive function and overall quality of life.
Attend another follow-up at 90 days to evaluate hospital readmissions and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip fracture
排除标准
- •Pathological hip fracture
- •Periprosthtic fracture
- •Unable to speak or understand Danish
- •Does not wish to recieve blood transfusion
- •If the investigator finds the patient unable to cooperate to the study (e.g. in case of severe dementia and externalizing behaviour)
研究组 & 干预措施
Immediate Transfusion Strategy
Vital parameters, delirium screening, and blood samples are collected three times a day. If the hemoglobin level falls below the predefined threshold, red blood cell transfusion is administered without delay (within 4 hours).
干预措施: Blood Transfusion (Other)
Standard Care with Delayed Hemoglobin analysis
The patients recieve standard care. To maintain patient blinding vital parameters, delirium screening, and blood samples are collected three times a day, just as in the intervention arm, however, hemoglobin analysis is delayed to avoid influencing transfusion decisions.
干预措施: Standard care (Other)
结局指标
主要结局
Number of Participants with Delirium
时间窗: From enrollment to 48 hours after surgery
Occurence of delirium will be evaluted using screening methods three times a day.
次要结局
- Change from baseline in Quality of Life(Will be evaluated at the 30 day follow-up)
- Cognitive status(Will be evaluated at the 30 day follow-up.)
- Readmission rate(Within 90 days after surgery)
- 90-day mortality(90 days after surgery.)