跳至主要内容
临床试验/NCT07077954
NCT07077954已完成1 期

COMPARISON OF THE EFFECTIVITY OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS

Children Hospital and Institute of Child Health, Lahore1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年1月20日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
74
试验地点
1
主要终点
Recanalization

研究概览

简要总结

This was a randomized controlled trial conducted at General Surgical wards of Mayo Hospital, Lahore.Total 74(37 in each group) patients were included.After heparinizing patients for 48 hours (80 units/kg/stat and 18 units/kg/hour), patients in group-A were started Warfarin (5mg PO/OD), and patients in group-B received Rivaroxaban (15 mg PO/BD) for 21 days and then 20 mg PO/OD for 6 months. The dose of Warfarin was titrated according to INR (monitored on alternate days). Patients were discharged when limb girth was normal, as compared to opposite limb and pain was calmed. Length of stay was noted on day of discharge. Patient were followed on 6th and 12thweeks with doppler USGto assess the recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein, percentage of recanalized segments was calculated out of total segments

详细描述

After approval from IRB, 74 patients meeting selection criteria were carefully chosen from all general surgical wards of Mayo Hospital. Informed written consent form was taken from all patients. Patients were randomized using lottery method and divided into two groups, A and B. History and clinical examination findings were noted. All baselines including INR was noted. USG Doppler findings documenting presence of thrombus in vein segments from common femoral to popliteal vein was noted. After heparinizing patients for 48 hours (80 units/kg stat and 18 units/kg per hour), patients in group A werestarted Warfarin (5mg PO OD), and patients in group B were given Rivaroxaban (15 mg PO BD) for 21 days and then 20 mg PO OD for 6 months. The dose of Warfarin was titrated according to INR (monitored on alternate days). While admitted in ward, monitoring was done for clinical improvement, including limb girth and pain severity.

Pain was assessed on scale of zero to 10, where 10 is most severe pain that patient ever had and zero is no pain at all. Limb girth was measured at mid-thigh, between greater trochanter and tibial tuberosity and compared to opposite limb and difference in limb girth was noted. Patients were discharged when limb girth was normal, as compared to opposite limb and pain was calmed. Length of stay was noted on day of discharge. Patient was kept on 6 weekly follow up till 12 weeks. Doppler USG was performed at 6 and 12 weeks to assess the recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein, percentage of recanalized segments was calculated out of total segments at 6 and 12 weeks. Those patients, who were be able to come in person, were followed through telemedicine. All this data was recorded in proforma. After collection of data; length of stay and percentage of segments recanalized at 6 and 12 weeks were compared between groups.

Data Analysis Procedure Data was entered in SPSS v26.0. Quantitative variables including age and LOS was presented as Mean±SD. Qualitative variables including gender, vessel recanalization, was presented as frequency and percentages. Chi square test was applied to compare Recanalized segments between groups at 6th and 12th week post treatment respectively. Independent t-test was applied and p-value less than 0.05 was taken significant.

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
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of all genders aged between 16-70years presenting with clinical features (pain and swelling) of lower limb DVT, evidenced by USG Doppler. Thrombosis present in common femoral, superficial femoral, deep femoral and popliteal veins in one lower limb were included.

排除标准

  • Exclusion Criteria: Patients taking other medications that can interact with warfarin or Rivaroxaban including aspirin, ibuprofen, clarithromycin, antihistamines, and SSRIs.Patients with co-morbid conditions that can affect coagulation, including CLD and CKD (CrCl<30), documented in previous hospital records. Pregnant and lactating females were excluded.

研究组 & 干预措施

Rivaroxaban

Experimental

Rivaroxaban given for DVT

干预措施: Rivaroxaban (Drug)

Warfarin

Experimental

Warfarin given for DVT

干预措施: Warfarin (Drug)

结局指标

主要结局

Recanalization

时间窗: 12 weeks

recanalization of all four segments including common femoral, superficial femoral, deep femoral and popliteal vein

次要结局

未报告次要终点

研究者

发起方
Children Hospital and Institute of Child Health, Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Adeel Ashiq

Senior Registrar

Children Hospital and Institute of Child Health, Lahore

研究点 (1)

Loading locations...

相似试验