Alameri Mariam A, Syed Sulaiman Syed A, Ashour Abdullah M, Al-Saati Ma'ad F
Department of Clinical Pharmacy, School of Pharmaceutical Science, University of Science Malaysia. Penang (Malaysia).
Director. Advanced Institute of Medicine and Dentistry, University of Science Malaysia. Penang (Malaysia).
Pharm Pract (Granada). 2020 Jul-Sep;18(3):2025. doi: 10.18549/PharmPract.2020.3.2025. Epub 2020 Sep 22.
Total knee replacement (TKR) is a major orthopedic surgery that is considered high risk for the development of venous thromboembolism (VTE).
The aim of this study is to evaluate the clinical outcomes that resulted from the use of a new proposed VTE risk stratification protocol for selecting a suitable extended VTE prophylaxis for post TKR surgery patients administered in conjunction with patient education programs.
A randomized controlled trial was conducted in two medical centers in Saudi Arabia. A total of 242 patients were enrolled in the study, 121 patients in each group. The experimental group (A) was assessed by using the proposed VTE risk stratification protocol and also took part in patient education programs about TKR and its complications. The control group (B) was assessed by using the 2005 Caprini risk assessment tool and no education programs were given to this group. Both groups were followed for 35 days post operation.
The mean age of the participants was 65.86 (SD 8.67) and the majority of them were female 137 (56.6%). The mean body mass index of the study sample was 32.46 (SD 5.51). There were no significant differences between the two groups except for surgery type; the proportion of bilateral TKR in group A was higher than in group B (69/121 (28.5%) vs. 40/121(16.5%), p<0.05). There were no confirmed pulmonary embolism cases in the study sample and diagnosis of deep-vein thrombosis was confirmed in 12/242 (5.0%) of patients: 1/121 (0.8%) in group A and 11/121 (9.1%) in group B (p<0.05). The readmission rate for all patients was 2.5% (6/242), all of whom were in group B (p<0.05).
The proposed VTE risk stratification protocol that was applied in conjunction with patient education programs reduced VTE complications and readmission events, post TKR surgery. Trial Registration: ClinicalTrials.gov: Identifier: NCT04031859.
全膝关节置换术（TKR）是一种大型骨科手术，被认为发生静脉血栓栓塞症（VTE）的风险很高。
本研究的目的是评估一种新提出的VTE风险分层方案的临床效果，该方案用于为接受TKR手术后的患者选择合适的延长VTE预防措施，并结合患者教育项目。
在沙特阿拉伯的两个医疗中心进行了一项随机对照试验。共有242名患者参与研究，每组121名患者。实验组（A组）采用新提出的VTE风险分层方案进行评估，并参加有关TKR及其并发症的患者教育项目。对照组（B组）采用2005年Caprini风险评估工具进行评估，该组未接受教育项目。两组患者术后均随访35天。
参与者的平均年龄为65.86岁（标准差8.67），其中大多数为女性，共137名（56.6%）。研究样本的平均体重指数为32.46（标准差5.51）。除手术类型外，两组之间无显著差异；A组双侧TKR的比例高于B组（69/121（28.5%）对40/121（16.5%），p<0.05）。研究样本中无确诊的肺栓塞病例，12/242（5.0%）的患者确诊为深静脉血栓形成：A组1/121（0.8%），B组11/121（9.1%）（p<0.05）。所有患者的再入院率为2.5%（6/242），均在B组（p<0.05）。
新提出的VTE风险分层方案结合患者教育项目，降低了TKR手术后的VTE并发症和再入院事件。试验注册：ClinicalTrials.gov：标识符：NCT04031859。
