Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients (EFFP-TDP)

Sheikh Hasina National Institute of Burn and Plastic Surgery

Status: Active, not recruiting

Conditions: Dengue Hemorrhagic Fever; Dengue Shock Syndrome; Dengue Fever

Treatments: Biological: Fresh frozen plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT06642493

SHNIBPS: June2024/03

Details and patient eligibility

About

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.

Full description

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:

1. Assess the effect of plasma transfusion on aPTT in non-bleeding thrombocytopenic dengue patients.
2. Evaluate the clinical outcomes, including the incidence of bleeding complications, in patients receiving plasma transfusion.
3. Determine the safety and feasibility of plasma transfusion in this patient population.
4. Measure changes in other coagulation parameters such as prothrombin time (PT) and fibrinogen levels post-transfusion.
5. Observe overall clinical outcomes, including the length of hospital stay and mortality rates.

Study Design:

This is a randomized controlled trial (RCT) involving non-bleeding thrombocytopenic dengue patients with elevated aPTT.

Study Population:

• Inclusion Criteria:** Patients diagnosed with dengue fever, thrombocytopenia (platelet count < 50,000/μL), and elevated aPTT (> 40 seconds) without active bleeding.
• Exclusion Criteria: Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.

Sample Size:

A total of 300 patients will be recruited. 150 patients will be assigned to the intervention group (receiving plasma transfusion) and 150 patients to the control group (receiving standard supportive care).

Intervention:

Patients in the intervention group will receive fresh frozen plasma (FFP) transfusion at a dose of 10-15 mL/kg body weight. The control group will receive standard supportive care without plasma transfusion.

Outcome Measures:

• Primary Outcome: Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
• Secondary Outcomes: 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 overall mortality rate within 30 days.

Data Collection:

Blood samples will be collected at baseline, 24 hours, and 48 hours post-transfusion to measure aPTT and other coagulation parameters. Clinical data, including bleeding episodes and other adverse events, will be recorded throughout the hospital stay.

Statistical Analysis:

Data will be analyzed using appropriate statistical methods. Continuous variables will be compared using t-tests or Mann-Whitney U tests, while categorical variables will be compared using chi-square tests. A p-value of < 0.05 will be considered statistically significant.

Ethical Considerations:

The study will be conducted in accordance with the Declaration of Helsinki and will be approved by the institutional ethics committee. Informed consent will be obtained from all participants or their legal guardians.

Expected Outcomes:

It is anticipated that plasma transfusion will normalize aPTT and improve coagulation parameters in non-bleeding thrombocytopenic dengue patients, thereby reducing the risk of bleeding complications and improving overall clinical outcomes.

Timeline:

• Study Design and Ethical Approval: 1 month
• Patient Recruitment and Data Collection: 3 months
• Data Analysis and Interpretation: 1 month
• Manuscript Preparation and Submission: 1 month

Budget:

The budget will cover the costs of plasma units, laboratory tests, personnel salaries, and other administrative expenses. A detailed budget will be provided upon approval of the proposal.

Conclusion:

This study aims to provide evidence on the efficacy and safety of plasma transfusion in managing coagulopathy in non-bleeding thrombocytopenic dengue patients. Positive findings could lead to the incorporation of plasma transfusion into the standard care protocols, potentially improving patient outcomes in dengue-endemic regions.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with dengue fever, thrombocytopenia (platelet count < 100,000/μL), and elevated aPTT (> 40 seconds) without active bleeding.

Exclusion criteria

• Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

300 participants in 2 patient groups, including a placebo group

Arm 1: Intervention Arm Title: Plasma Transfusion.

Experimental group

Description:

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.

Treatment:

Biological: Fresh frozen plasma

Arm 2: Control Arm Title: Standard Supportive Care

Placebo Comparator group

Description:

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.

Treatment:

Biological: Fresh frozen plasma