CTRI/2025/01/078960已完成Unknown
A Prospective, multicenter Observational Study to Determine the clinicoepidemiological profile of Indian Patients Presenting with Hypovolemia and to evaluate the Safety and effectiveness of Polygeline
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 5
- 主要终点
- 1. Demographic profile - Age, gender, education and occupation.
研究概览
简要总结
Post-Marketing Observational Study to determine the clinicoepidemiological characteristics in Indian Patients Presenting with Hypovolemia and to evaluate the Safety and effectiveness of Polygeline There is only one visit in the study i.e., Screening, Enrolment and Treatment on the same day
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects will be included in the study based on the following criteria
- •Male and female patient’s ≥18 to 65 years of age.
- •Informed consent will be primarily obtained from patient’s Legally Acceptable Representative (LAR) or patient themselves when they could give consent.
- •Adult patients who present with symptoms of hypovolemia and who have been prescribed IV Polygeline as per the discretion of the investigator will be included in the study.
- •Patients presenting with Class II or III of hypovolemia due to hemorrhage (per Advanced Trauma Life Support criteria of acute hemorrhage).
排除标准
- •The subject will be excluded from the study if they meet any of the following criteria:
- •Patients with hypersensitivity to Polygeline or any other constituent.
- •Pregnant and breast-feeding women, patients with concomitant asthma and unconscious patients.
- •Patients who are critically ill, as per the discretion of the investigator.
- •Patients who have been given Hydroxyethyl starch (HES), Albumin, other gelatins (gelofusine) or any other kind of synthetic colloid.
结局指标
主要结局
1. Demographic profile - Age, gender, education and occupation.
时间窗: 24 Hrs
2. Clinico-epidemiological – Classification of hypovolemia, volume of blood loss, cause of hypovolemia.
时间窗: 24 Hrs
次要结局
- To determine effectiveness(A. Change from baseline at every hour till 6 hrs. and then at 10 hrs., 14 hrs., 18 hrs. and 24 hrs.)
研究者
Mr Jamnadas Kushwaha
Raptim Research private Ltd
研究点 (5)
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