To evaluate the effectiveness and safety of IM Anti D for the management of thrombocytopenia in a patient of dengue fever in a tertiary care teaching hospital
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- A sample size of subjects 46 (23 in each group) is estimated using platelet count at 48 hours of dengue patients, at 95% confidence interval 80% power and a 5% level of significance. By considering 10% attrition rate the final sample size will be 50 (25 per group)
研究概览
简要总结
Dengue is vector-borne disease. Though self limiting , it can have a phase of critical defervescence. Thrombocytopenia and platelet dysfunction are common and are related to clinical outcomes.
Efficacy of empirical and therapeutic platelet transfusion is not proven in DHF/DSS patients with severe thrombocytopenia without bleeding manifestations .Intravenous Anti D has been successfully used in ITP7 . It also seems to be an effective, promising therapy in Rh+ DHF with severe thrombocytopenia.
Okwundu C I et.al have compared the efficacy and effectiveness of IM versus IV anti-D IgG in preventing RhD alloimmunization in RhD-negative pregnant women and were found to be equally effective.
(Okwundu CI, Afolabi BB. Intramuscular versus intravenous antiâ€D for preventing Rhesus alloimmunization during pregnancy. Cochrane Database of Systematic Reviews. 2013)
On this basis, we suggest use of intramuscular Anti D in Dengue associated thrombocytopenia which will bridge the existing gap in terms of effectiveness, cost and availability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Rh+ patients , non-splenectomy with serology proven dengue positivity, thrombocytopenia14 (platelet count 50,000-90,000/mm3.
排除标准
- •DHF15patients/DSS patient
- •Dengue patients with platelet count ≥90,000/mm3, Rh−, and pregnant females, and teenagers below 18yrs , patients with bleeding tendencies & coagulation disorders, patients on anticoagulants , patients on NSAIDs, or any other drug which might interfere with platelets ,Hb less than 8g/dl, patient will be excluded from the study.
结局指标
主要结局
A sample size of subjects 46 (23 in each group) is estimated using platelet count at 48 hours of dengue patients, at 95% confidence interval 80% power and a 5% level of significance. By considering 10% attrition rate the final sample size will be 50 (25 per group)
时间窗: Day 1 or Day 3 or Day 5 of the recruitment schedule. | This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening
Therefore, we will include at least 50 (25 per group) dengue patients in this study.
时间窗: Day 1 or Day 3 or Day 5 of the recruitment schedule. | This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening
-value less than 5% will be consider statistically significant.
时间窗: Day 1 or Day 3 or Day 5 of the recruitment schedule. | This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening
次要结局
- To see the platelet rise after the first dose of anti d, or the second or the third, same as primary outcome(Day 1 or Day 3 or Day 5 of the recruitment schedule.)
研究者
Dr. Smita Avhad
GMC&MPGIMER,MUHS Nashik