A Prospective,cross sectional study to find out incidence of deep vein thrombosis in high risk patients undergoing spine surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Positive venous color doppler study of lower limbs for diagnosing deep vein thrombosis.
研究概览
简要总结
This is a single centre,prospective,observational study. In this study, all the high risk patients undergoing spine surgery will be screened for DVT and followed upto 6 weeks following surgery. A total of two hundred and fifty ( 250) patients, who met the inclusion exclusion criteria will be enrolled in the study. Patients will be screened for deep vein thrombosis by venous colour doppler of lower limbs, and at 6 weeks following surgery. There will be 2 years maximum patient recruitment period. The total duration of this study is expected to be upto 6 weeks for the patient enrolled. All patients with confirmed DVT will receive standard therapeutic anticoagulant therapy or intervention as will be advised by the vascular surgeons and physician.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.99 Year(s)（—）
- 性别
- All
入选标准
- •Patients are included in the study if they are undergoing spine surgery at Stavya Spine Hospital and Research Institute with any of the following criteria: 1.Malignancy: present or past within 6 months 2.Hematological disorder (Thrombophilia, High factor VIII levels, antithrombin deficiency, protein c deficiency, protein s deficiency, high fibrinogen levels, high factor IX levels, high factor XI levels, leukemia, thrombocytosis) 3.Immobilisation- 72 hours 4.Past history of DVT 5.Varicose veins 6.Spine infection 7.Obesity (BMI > 30) 8.Age > 65 years 9.Myelopathy with Nurick’s Grade 3 or more than 3 10.ASIA Impairment scale (AIS) grade A/B/C 11.Long duration of surgery > 2 hours.
排除标准
- •Patients are excluded from participating in this study if any of the following criteria are met: 1.Patient not fulfilling inclusion criteria 2.Patient not willing to participate in the study or not willing to sign the consent form.
- •3.Active local infection of lower limb like cellulitis.
- •4.Active hepatitis (receiving medical treatment within two years); 5.Pregnant or planning to become pregnant during study period; 6.Patients who have limited life expectancy due to significant medical comorbidities.
- •7.Known or documented history of communicable disease, including AIDS or HIV; 8.Immunologically suppressed, history of Paget’s disease, osteomalacia, or any other metabolic bone disease; 9.Active hepatitis (receiving medical treatment within two years).
结局指标
主要结局
Positive venous color doppler study of lower limbs for diagnosing deep vein thrombosis.
时间窗: The assessment will be made preoperatively on admission and approximate 6 weeks after surgery
次要结局
未报告次要终点