A retrospective cohort study on macrophage activation syndrome in Indian Patients with systemic lupus erythematosus: clinical features, laboratory abnormalities and treatment outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Resolution of MAS: Defined by clinical improvement and normalization of laboratory markers (ferritin, liver enzymes, blood counts) after treatment.
研究概览
简要总结
This is retrospective cohort study where patients of SLE (Satisfying ACR/EULAR 2019
classification criteria) would be enrolled if they satisfy at least one of the three prevalent
criteria for diagnosing primary or secondary Hemophagocytic Lymphohistiocytosis
(HLH)7,8,9. History, clinical examination findings and investigations done at the time of
diagnosis of macrophage activation are enrolled in the case record form. No additional
investigations are being done as a part of this study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Day(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of SLE as per ACR/EULAR 2019 classification criteria10 Diagnosed as a case of MAS as per one of the three above-mentioned criteria Diagnosed to have MAS between 2004 to 2024.
排除标准
- •Unclear diagnosis of MAS (i.e. not satisfying either of the three mentioned criteria) MAS because of causes other than SLE disease activity.
结局指标
主要结局
Resolution of MAS: Defined by clinical improvement and normalization of laboratory markers (ferritin, liver enzymes, blood counts) after treatment.
时间窗: Since it’s retrospective, time points can be based on clinical records: | 1. Baseline: At MAS diagnosis (clinical presentation and lab abnormalities). | 2. Early Response: Within 7 days of initiating treatment. | 3. Intermediate Response: 2–4 weeks after treatment initiation. | 4. Final Outcome: At 3 months post-diagnosis or last follow-up.
Time to Resolution: Duration from diagnosis of MAS to clinical and laboratory resolution.
时间窗: Since it’s retrospective, time points can be based on clinical records: | 1. Baseline: At MAS diagnosis (clinical presentation and lab abnormalities). | 2. Early Response: Within 7 days of initiating treatment. | 3. Intermediate Response: 2–4 weeks after treatment initiation. | 4. Final Outcome: At 3 months post-diagnosis or last follow-up.
次要结局
- Secondary Outcomes for MAS in SLE Study(1. Clinical Outcomes)
研究者
Dr Nilesh Nolkha
Topiwala National Medical College