Clinical trial NCT06642493: Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients
Official title: Efficacy of Fresh Frozen Plasma (Ffp) in the Treatment of Thrombocytopenia in Dengue Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dengue Fever
Dengue Hemorrhagic Fever
Dengue Shock Syndrome
Keywords: Dengue fever
Thrombocytopenia
Plasma transfusion
Elevated aPTT
Coagulopathy in dengue
Non-bleeding dengue complications
Hemostatic management in dengue
Lead sponsor: Sheikh Hasina National Institute of Burn and Plastic Surgery
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this model, participants are randomly assigned to one of two or more groups (arms) simultaneously, with each group receiving a different intervention or control treatment. The outcomes of each group are then compared to assess the efficacy and safety of the interventions.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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 \&lt; 50,000/μL), and elevated aPTT (\&gt; 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 \&lt; 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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with dengue fever, thrombocytopenia (platelet count \&lt; 100,000/μL), and elevated aPTT (\&gt; 40 seconds) without active bleeding.

Exclusion Criteria:

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

Primary outcomes:
measure: Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
timeFrame: 24 to 48 hours
Secondary outcomes:
measure: 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
timeFrame: 30 days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: SheikhHasinaNIBPS
Study officials:
affiliation: Sheikh Hasina National Institute of Burn & Plastic Surgery
name: Ashraful Hoque, DBST
role: PRINCIPAL_INVESTIGATOR
References:
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