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临床试验/NCT02650856
NCT02650856已完成3 期

Blood Loss Reduction After Total Knee Arthroplasty. A Comparison Between Topical Tranexamic Acid and Platelet Rich Plasma: Controlled Clinical Trial

Universidad Autonoma de Nuevo Leon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Therapeutic Effect on Hemoglobin Level

研究概览

简要总结

The investigators will include patients who will be schedule for total knee arthroplasty with a diagnosis of osteoarthritis. The patients will be divided in two groups. In both groups a verbal and clear detailed information will be given on the intraoperative approach. The first group will receive topical tranexamic acid and the second group topical platelet rich plasma; both in the surgical site. Both groups will be assessed before and after the intervention with laboratory results (hemoglobin, hematocrit levels) and drainage drain.

详细描述

Total knee replacement (TKR) surgery is one the most common orthopedic procedure in the world. Morbidity in perioperative TKR is associated with: blood loss, pain, infection, wound complications, stiffness, and thrombotic events. Blood loss and transfusion have been associated with an increased hospital stay, costs, morbidity, and mortality. Indications for blood transfusions are now limited and it is well known that is not a free risk procedure. Complications such as; ABO incompatibility, viral transmission, hemolysis, immunosuppression, and wound infection have been reported.

Literature reports have reported blood loss in TKR ranging from 300ml to 1 liter, and transfusion rate varying from 10-38%. In diminishing hospital cost Moskal J. et al. reported 53.90% of savings and a 100% reduction in working hours of the hospital staff using topical tranexamic acid in TKR. Tranexamic acid is an antifibrinolytic agent that acts inhibiting the plasminogen, stabilizing the blood clot; it is used to stop surgical or traumatic bleeding like in the CRASH-2 trial, demonstrating its efficiency in polytraumatized patients. Tranexamic acid has been used in the last years for blood loss with good results. Due to its systemic effects and past medical history of myocardial infarction, stents, and previous thromboembolic events its intravenous use is limited. In this study, the investigators used topical tranexamic acid and its use has been proven in clinical trials as a secure strategy for blood loss reduction in TKR, without excluding patients with previous thromboembolic events.

Platelet-rich plasma (PRP) is an orthobiologic that has played an important role over the past decade in different areas like; spinal fusion, anterior cruciate ligament reconstruction, osteoarthritis, and tendinopathies. The use of PRP in orthopedics is overrated and true indications for its use and cost-benefit are still unclear. Retrospective studies like Pace T et al in 268 patients did not demonstrate differences in-hospital stay, Postoperative hemoglobin levels, and range of motion using PRP in TKR. Morishita M. et al. in a clinical trial of 40 patients, using intralesional PRP didn´t show any benefits for blood loss reduction in TKR, but good clinical results were observed in clinical scores like Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analog Scale (VAS) compared to the control group. Other studies have demonstrated the efficacy of topical PRP in blood loss reduction in TKR.

Due to its high platelet concentration and growth factors contained in the alfa granules; it is used as a hemostatic, analgesic, and antiseptic agent in TKR.

There is a variety of blood loss prevention strategies for TKR and these strategies can be divided into preoperative, intraoperative, or postoperative. This study aimed to compare the use of topical tranexamic acid versus topical platelet-rich plasma.

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

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Patient candidates for primary total knee replacement
  • Patients willing to participate in the study and sign de inform consent

排除标准

  • Patients with previous history of thromboembolic event in the last 6 months
  • Patients candidates for revision total knee replacement
  • Patients candidates for tumoral total knee replacement
  • Patients candidates for bilateral total knee replacement
  • Patient with cognitive deficit
  • Previous history of coagulopathy

研究组 & 干预措施

Group 1 Tranexamic acid

Experimental

A dosis of 2 gr of tranexamic acid (1000mg/10ml X-GEN pharmaceuticals inc.) diluted in 80ml of physiologic solution and will be divided in two applications.

First application: 40ml of the solution previously prepared is applied over the surgical site and it will be left for five minutes then drained out completely by suction.

Second application: The rest of 40ml of solution previously prepared is applied after placing the final TKR components (femoral, tibial and patellar), over the surgical site and leaving it without draining it by suction.

干预措施: Group 1 Tranexamic Acid (Drug)

Group 2 Platelet rich plasma

Active Comparator

A final volumen of 16 ml of platelet rich plasma is obtained from the forearm vein of the patient and will be divided in two applications.

First application: 8 ml of PRP are applied over the surgical site and are left for five minutes then drained out completely by suction.

Second application: The rest of the 8 ml are applied after placing the final TKR cemented components (femoral, tibial and patellar), over the surgical site and leaving it without draining.

干预措施: Group 2 Platelet rich plasma (Biological)

结局指标

主要结局

Therapeutic Effect on Hemoglobin Level

时间窗: up to 3rd day post operative (Baseline, 24, 48 and 72hrs)

The blood test will be taken at 6am every day. Using the same laboratory parameters.

次要结局

  • Therapeutic Effect on Drainage Quantification(up to 2nd day post operative (24 and 48 hrs))
  • Therapeutic Effect on Hematocrit Level(up to 3rd day post operative (Baseline, 24, 48 and 72hrs))

研究者

发起方
Universidad Autonoma de Nuevo Leon
申办方类型
Other
责任方
Principal Investigator
主要研究者

FELIX VILCHEZ CAVAZOS

Dr. med. José Félix Vilchez Cavazos

Universidad Autonoma de Nuevo Leon

研究点 (1)

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