Impact of Surgical Injury on Global Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Bone Neoplasm. A Single-centre Observational Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- INTEM parameters change from preoperative to postoperative values
研究概览
简要总结
Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients undergoing primary elective total hip replacement
排除标准
- •Patients unable to consent to trial
- •Active deep and superficial vein thrombosis
- •Coagulopathy in initial coagulation screen tests
- •Platelet count below 100 thousand
- •Patients on antithrombotic medications (except prophylactic low molecular weight heparins and acetylsalicylic acid up to 75 mg per day)
- •Preoperative haemoglobin < 10 g/dl
- •Female patients who are pregnant or nursing
结局指标
主要结局
INTEM parameters change from preoperative to postoperative values
时间窗: 30 minutes before and 30 minutes after surgery
EXTEM parameters change from preoperative to postoperative values
时间窗: 30 minutes before and 30 minutes after surgery
FIBTEM parameter change from preoperative to postoperative values
时间窗: 30 minutes before and 30 minutes after surgery
次要结局
- Total volume of infused fluids(From first fluid on day of surgery to end of surgery, an average of 12 hours)
- Pre- and postoperative haemoglobin and haematocrit(From day before surgery to postoperative day 3)
- Intraoperative blood loss(Blood loss as measured during surgery)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)
- The 36-Item Short Form Health Survey (SF-36)(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)
- Visual Analogue Scale (VAS) score(The day before surgery and at 6 ± 1 months, 12 ± 1 month after surgery)
研究者
Jan Pluta
Principal Investigator
Medical University of Warsaw