A PROSPECTIVE RANDOMIZED EVALUATOR BLINDED, ACTIVE CONTROLLED PARALLEL GROUP CLINICAL STUDY TO EVALUATE SAFETY AND EFFICACY OF HEPARIN SODIUM TOPICAL SOLUTION (1000 IU/ ML) COMPARED TO HEPARIN SODIUM (200 IU/ GM) TOPICAL GEL IN PREVENTION OF INFUSION ASSOCIATED PHLEBITIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- PGIMER
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1 Proportion of patients with no phlebitis (Grade 0) at the end of 72 hours of treatment period
研究概览
简要总结
In this study, topical heparin was effective in reducing the incidence of development and progression of infusion related superficial venous thrombophlebitis. Topical heparin solution had significantly higher proportion of patients in whom no signs of phlebitis developed at the end of 72 hours, when compared to heparin gel. In other words, topical heparin therapy was effective in preventing infusion related SVT in patients with in situ catheter for 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Planned to undergo peripheral vein cannulation that has been planned to remain in situ for at least 72 hours of indoor period 2 Willing & able to comply with study requirements, e.g. application of IP and study visit schedule, as indicated by written informed consent provided by the patient.
- •3 If female of childbearing potential: non-pregnant (supported by negative urine pregnancy test at screening), non-lactating and willing to maintain reliable birth control throughout the study.
排除标准
- •1 Undergoing re-cannulation due to phlebitis at earlier cannulation site 2 History of hypersensitivity reaction to heparin or heparin induced thrombocytopenia 3 Signs of systemic infection, bacteremia 4 Planned administration of any of the following during study period Anti-coagulants locally (in the cannula) or systemically NSAIDs locally (in the cannula or over surrounding area).
结局指标
主要结局
1 Proportion of patients with no phlebitis (Grade 0) at the end of 72 hours of treatment period
时间窗: Enrolled patients will be periodically monitored by evaluator every 8 hours from cannulation for infusion phlebitis grade as per visual infusion phlebitis scale | time points are 0 8 16 24 32 40 48 56 64 72
2 Proportion of patients who developed first signs of infusion phlebitis (Grade I and II) during the 72 hours of treatment period
时间窗: Enrolled patients will be periodically monitored by evaluator every 8 hours from cannulation for infusion phlebitis grade as per visual infusion phlebitis scale | time points are 0 8 16 24 32 40 48 56 64 72
次要结局
- Mean time to reach infusion phlebitis grade I and II in hours based on the time point when patient was first found to have phlebitis grade I or II. Only the proportion of patients who developed grade I and II phlebitis were considered for the evaluation of mean time to develop grade I and II phlebitis(time points are 0 8 16 24 32 40 48 56 64 72)