Efficacy of Fresh Frozen Plasma (Ffp) in the Treatment of Thrombocytopenia in Dengue Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
研究概览
简要总结
This clinical trial seeks to assess the effectiveness of fresh frozen plasma (FFP) in the treatment of thrombocytopenia in individuals with dengue. Dengue is a viral infection marked by thrombocytopenia, potentially resulting in significant hemorrhagic consequences. FFP is frequently utilized in the management of coagulopathies, and this study will investigate its efficacy in enhancing platelet count and mitigating bleeding risks in dengue patients with thrombocytopenia. The research will be executed as a randomized, controlled trial to evaluate outcomes in patients receiving routine care with and without FFP transfusion.
详细描述
Background:
Dengue fever is a mosquito-borne viral disease prevalent in tropical and subtropical regions. Severe dengue can lead to complications such as thrombocytopenia (low platelet count) and coagulopathy, indicated by prolonged activated partial thromboplastin time (aPTT). While platelet transfusions are commonly used to manage thrombocytopenia, the potential benefits of plasma transfusion in non-bleeding thrombocytopenic dengue patients with elevated aPTT remain unexplored. Plasma contains essential coagulation factors that might normalize aPTT and stabilize the hemostatic system, preventing progression to bleeding episodes.
Hypothesis:
Plasma transfusion in non-bleeding thrombocytopenic dengue patients with elevated aPTT will improve coagulation parameters and reduce the risk of bleeding complications.
Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with dengue fever, thrombocytopenia (platelet count < 100,000/μL), and elevated aPTT (> 40 seconds) without active bleeding.
排除标准
- •Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.
研究组 & 干预措施
Arm 1: Intervention Arm Title: Plasma Transfusion.
Arm 1: Intervention Arm Title: Plasma Transfusion Description: Participants in this arm will receive fresh frozen plasma (FFP) transfusion at a dose of 10-15 mL/kg body weight.
Intervention:
Type: Biological Name: Fresh Frozen Plasma (FFP) Description: Administration of FFP to correct coagulopathy and normalize aPTT.
干预措施: Fresh frozen plasma (Biological)
Arm 2: Control Arm Title: Standard Supportive Care
Arm 2: Control Arm Title: Standard Supportive Care Description: Participants in this arm will receive standard supportive care without plasma transfusion.
Intervention:
Type: Other Name: Standard Supportive Care Description: Standard medical management without the administration of plasma transfusion.
干预措施: Fresh frozen plasma (Biological)
结局指标
主要结局
Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
时间窗: 24 to 48 hours
Platelet count change from baseline (pre-intervention) to 48 hours post-transfusion. CBCs will be performed before FFP administration and 24 and 48 hours post-transfusion to measure platelets. The purpose is to determine if fresh frozen plasma (FFP) enhances platelet count in dengue-related thrombocytopenia patients compared to usual therapy without FFP.
次要结局
- Incidence of bleeding complications within 7 days post-transfusion, changes in other coagulation parameters (PT, fibrinogen levels) from baseline to 24 and 48 hours post-transfusion, platelet count changes post-transfusion, length of hospital stay, and o(30 days)
研究者
Ashraful Hoque
Assistant Professor
Sheikh Hasina National Institute of Burn and Plastic Surgery