A Multi-center, Single Blinded Randomized Trial Investigating Indications Based Blood Transfusion Practices in Patients With Major Oncological Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 260
- 主要终点
- percentage of the postoperative complication
研究概览
简要总结
Investigators aimed to compare the effect on different indications (blood volume loss based VS hemoglobin concentration based ) based blood transfusion practices in patients undergoing major oncological surgery for pelvic or spinal tumor and investigate their postoperative complications.
详细描述
260 patients underwent major oncological surgery for open pelvic or spinal tumor resection were included in this study. We looked at white blood cells, hemoglobin, hematocrit, neutrophil ratio, C-reactive protein, erythrocyte sedimentation rate, and IL-6 levels 1 day, 3 days, and 7 days after surgery The main question it sought to answer was whether there was a difference in postoperative complications 30 days after surgery between patients who received blood transfusions based on volume loss and those who received blood transfusions based on hemoglobin concentration during surgery.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 70
- •patients with pelvic or spinal tumor
- •conduct open resection surgery for tumor removal
- •with expected surgery duration greater than 3 hours
- •with expected blood loss greater than 400 ml
排除标准
- •age < 18 or >70
- •Limb tumor patients or patients with pelvic and spinal tumors undergoing closed internal fixation or vertebroplasty or minimally invasive surgery
- •received chemotherapy or immunotherapy before surgery
- •with expected surgery length less than 3 hours
- •with expected intraoperative blood loss less than 400ml
结局指标
主要结局
percentage of the postoperative complication
时间窗: patients were carefully followed for complication occurrence 1 month after surgery.
Major postoperative complications include but are not limited to surgical site infection, lung infection, deep vein thrombosis, pressure ulcers and so on
次要结局
- transfusion of red packed blood cells(during hospitalization after surgery, an averagy of 1 week)
- length of hospital stay(during hospitalization after surgery, an averagy of 1 week)
- neutrophil ratio(1 day，3 days，7 days，and 30 days after surgery)
- hemoglobin level(1 day，3 days，7 days，and 30 days after surgery)
- C-reactive protein(1 day，3 days，7 days，and 30 days after surgery)
- White blood cell count(1 day，3 days，7 days，and 30 days after surgery)
- hematocrit(1 day，3 days，7 days，and 30 days after surgery)
- erythrocyte sedimentation rate(1 day，3 days，7 days，and 30 days after surgery)
- nterleukin-6 level(1 day，3 days，7 days，and 30 days after surgery)