Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Blood transfusion requirements
研究概览
简要总结
The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery
详细描述
All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).
Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.
Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.
In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.
A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients admitted to perform a primary unilateral total knee arthroplasty
排除标准
- •Contraindication to take tranexamic acid
- •hematologic disease with a higher risk of bleeding
- •abnormal coagulation tests
- •refusal of blood transfusions
- •inadequate preoperatory optimization
- •deformity >15⁰ of varus or valgus
结局指标
主要结局
Blood transfusion requirements
时间窗: 96 hours
Blood transfusions requirements
Knee Society Score score
时间窗: 14 days
Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)
Total RBC loss
时间窗: 1 hour
Total red blood cells loss after surgery
次要结局
- ROM(14 days)
- Haematocrit level(96 hours)
- Tourniquet duration(0 hour)
- Transfusion reactions(96 hours)
- Surgery duration(0hour)
- Surgical blood loss(0 hour)
- Iron(96 hours)
- Drain volume(24 hours)
- MKC(14 days)
- Haemoglobin level(96 hours)
- Length of skin incision(0 hour)
- Fluidotherapy excess(96 hours)
- Wound complications (i. e., wound dehiscence, infection)(14 days)
- Lower leg deep vein thrombosis(14 days)
研究者
Afonso Cardoso
Principal Investigator
Hospital Beatriz Ângelo