The Effectiveness of a Risk Stratification Procedure for Thromboembolism Prophylaxis After Total Knee Replacement Surgeries
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Bleeding events
研究概览
简要总结
The main objective for this study is validation for the proposed risk stratification tool, by evaluating the clinical outcomes for its use post TKR Surgeries. For this objective, the design that is used is Randomized Trial.
详细描述
All patients that will have total knee replacement, in a given period of time in both medical centers; Prince Sultan Military Medical City (PSMMC) and King Abd Allah University Hospital (KAAUH) in Princess Noura University, will be randomly separated into 2 groups; in the first group (A): Venous thromboembolism (VTE) risk stratification tool (which is prepared by a clinical pharmacist) will be applied to choose the tailored extended VTE prophylactic agent. While in the second group (B), the risk stratification tool will not be used, rather it will follow the routine hospital protocol for choosing the VTE prophylactic agent, which is Caprini: a standard validated model. Then each group of patients will be followed till 35 days post-operation, during which all VTE or bleeding events should be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Male or Female patients who are planned for elective TKR surgery (primary only).
- •Agreed to sign the Informed consent form (ICF).
- •Patients aged older than 18 years.
排除标准
- •Patients receiving anticoagulant for treatment.
- •Patients with a history of DVT or PE were excluded from the study due to the marked increase in the risk of recurrent VTE compared to the general risk of (7% vs. 0.1%); (Fahrni, 2015).
- •Patients with renal or hepatic failure, renal failure is defined as end-stage kidney disease (on dialysis); hepatic failure is defined as complete liver cirrhosis.
- •Pregnant woman.
- •Revision surgeries.
研究组 & 干预措施
Group A
In this group a VTE risk stratification procedure will be used
干预措施: acetylsalicylic acid (Drug)
结局指标
主要结局
Bleeding events
时间窗: 35 days post total Knee Replacement surgery
Major or minor bleeding will be recorded
Venous thromboembolism (VTE) complications
时间窗: 35 days post total Knee Replacement surgery
Deep vein thrombosis, pulmonary embolism, sudden death
次要结局
- Surgical site infection(35 days post total Knee Replacement surgery)
研究者
Mariam Ahmad Alameri, Clinical Pharmacist
Clinical Pharmacist
Ministry of Health, Saudi Arabia