The Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation
研究概览
简要总结
One postoperative complication following unilateral or bilateral total knee arthroplasty is thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled clinical trial, researchers are investigating the effect of steroids on biochemical markers of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have been linked to postoperative depression following total knee arthroplasty surgery. Hence the investigators are also checking if use of hydrocortisone, a steroid, may help reduce the incidence of postoperative depression.
Other studies have shown that surgery causes some reaction in the body that is consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body. It may also lead to clotting disorders and result in blood clots. In a previous study by this principal investigator (see reference 22, "Use of low-dose steroids in decreasing cytokine release during bilateral total knee arthroplasty"), hydrocortisone was administered over 24 hours following surgery to patients who underwent bilateral total knee arthroplasty. The investigator found lower levels of cellular markers consistent with inflammation (specifically the protein, IL-6). Steroid use also showed additional benefits, such as decreased pain and better range of motion at the knee.
In this study, investigators recruit patients undergoing total knee arthroplasty surgery. Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect on clotting factors (i.e. IL-6), investigators record patients' pain scores and patients' oral analgesic use. To assess patients' well-being, patients are contacted one month and 3 months following their surgeries and administered the Patient Health Questionnaire (see reference 23, "The PHQ-9: validity of a brief depression severity measure.") arthroplasty.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing unilateral or bilateral total knee replacement
- •Age 50-90
排除标准
- •All patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
- •Patients who are smokers
- •Patients under 50 years of age
- •Patients over 90 years of age
- •Patients with diabetes
- •Patients with a prior history of corticosteroid intolerance
- •Patients with previous complications of steroid use
研究组 & 干预措施
Placebo
Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.
干预措施: Placebo (Drug)
Treatment
Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Prothrombin Fragment (PF1.2), a Marker of Thrombin Generation
时间窗: Baseline and up to 4 hours following surgery
Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP
Plasmin-alpha-2-antiplasmin Complex (PAP), a Marker of Fibrinolysis
时间窗: Baseline and up to 4 hours following surgery
Study patients received 100 mg of intravenous hydrocortisone 2 h prior to surgery, and controls received normal saline. Blood samples, drawn pre-incision and at 4 h post tourniquet release, were assayed for PF1.2 and PAP
次要结局
- Hydrocortisone's Effect on Depression(one month and up to 3 months following surgery)
- Pain Scores and Opioid Consumption(one month and up to 3 months following surgery)
- Blinding Assessment(one month and up to 3 months following surgery)