Effect of Tranexamic Acid on Blood Loss and Transfusion Need in Patients Operated With a Short Intramedullary Nail, for Pertrochanteric Fractures .
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Total Blood Loss
研究概览
简要总结
The effect of Tranexamic acid on blood loss, hemoglobin and transfusions in patients with pertrochanteric hip fractures.
Tranexamic acid is a well known drug used in many types of surgery. The investigators wish to investigate if the use of tranexamic acid can reduce the peri- and post-operative blood loss in patients who undergo surgery with a short intramedullary nail, for a pertrochanteric hip fracture.
An interim analysis was planned when reaching 60 inclusions. The interim analysis was conducted only on the primary outcome (TBL). A difference in TBL of no less than 500 ml was considered a reason to halt the study. The 0.001 level was chosen as a simple approach to this interim analysis from the Haybittle-Peto boundary
详细描述
Studies have shown that hip fractures have a hidden blood loss besides the recorded perioperative blood loss. Patients who are osteosynthesised with an intramedullary nail have been shown to have the largest hidden blood loss.
Postoperative anaemia is associated with a higher morbidity and mortality. We wish to investigate the possibility of reducing this hidden blood loss, with the use of a well known drug (tranexamic acid) that is widely used to reduce blood loss in other forms of surgery and in multitraumatized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients planned to undergo osteosynthesis with short intramedullary nail for a pertrochanteric hip fracture.
- •ASA score 3, 2 or 1
排除标准
- •Allergy for tranexamic acid
- •Clinical signs of acute thromboembolic event
- •Renal function impairment (S-creatinin>120micromol/l)
- •Active thrombotic disease or DIC
- •K-vitamin antagonist treatment
- •Malignancy
- •Pathological fracture
- •Previously operated in same hip
- •BW > 100kg
研究组 & 干预措施
Placebo
Patients are given saline instead of tranexamic acid in the placebo group
干预措施: Placebo (Drug)
Tranexamic Acid
Tranexamic acid; 1 gram as a bolus prior to surgery. 3 grams of Tranexamic acid in 1 liter of saline as a 24 hour infusion.
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Total Blood Loss
时间窗: time in hospital (approximately 10 days)
Calculated as described by Foss et al in their study of 2006. "Hidden Blood Loss After Surgery for Hip Fracture" JBJS br. 2006.
次要结局
- Mortality(30 days and 90 days follow up)
- Transfusions(From admission to third day after surgery.)
- Thromboembolic Event (clinical, NOT by routine ultrasound measurement)(90 days follow up)
研究者
Peter Toft Tengberg
MD
Hvidovre University Hospital