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

NCT ID: NCT06642493

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-12-31

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 < 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.

Conditions

Dengue Fever; Dengue Hemorrhagic Fever; Dengue Shock Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fresh frozen plasma

Intervention Type: BIOLOGICAL

Intervention Type: Biological

• Intervention Name: Fresh Frozen Plasma (FFP)
• Detailed Description:
• Dosage:Fresh frozen plasma (FFP) will be administered at a dose of 10-15 mL/kg body weight.
• Administration: The FFP will be transfused intravenously under controlled clinical conditions.
• Purpose: The transfusion aims to correct coagulopathy and normalize activated partial thromboplastin time (aPTT) in non-bleeding thrombocytopenic dengue patients.
• Monitoring: Patients will be closely monitored for any adverse reactions or complications during and after the transfusion process. Coagulation parameters, including aPTT, will be measured at baseline, 24 hours, and 48 hours post-transfusion.

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.

Group Type: PLACEBO_COMPARATOR

Fresh frozen plasma

Intervention Type: BIOLOGICAL

Intervention Type: Biological

• Intervention Name: Fresh Frozen Plasma (FFP)
• Detailed Description:
• Dosage:Fresh frozen plasma (FFP) will be administered at a dose of 10-15 mL/kg body weight.
• Administration: The FFP will be transfused intravenously under controlled clinical conditions.
• Purpose: The transfusion aims to correct coagulopathy and normalize activated partial thromboplastin time (aPTT) in non-bleeding thrombocytopenic dengue patients.
• Monitoring: Patients will be closely monitored for any adverse reactions or complications during and after the transfusion process. Coagulation parameters, including aPTT, will be measured at baseline, 24 hours, and 48 hours post-transfusion.

Interventions

Fresh frozen plasma

Intervention Type: Biological

• Intervention Name: Fresh Frozen Plasma (FFP)
• Detailed Description:
• Dosage:Fresh frozen plasma (FFP) will be administered at a dose of 10-15 mL/kg body weight.
• Administration: The FFP will be transfused intravenously under controlled clinical conditions.
• Purpose: The transfusion aims to correct coagulopathy and normalize activated partial thromboplastin time (aPTT) in non-bleeding thrombocytopenic dengue patients.
• Monitoring: Patients will be closely monitored for any adverse reactions or complications during and after the transfusion process. Coagulation parameters, including aPTT, will be measured at baseline, 24 hours, and 48 hours post-transfusion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheikh Hasina National Institute of Burn and Plastic Surgery

OTHER

Sponsor Role: lead

Responsible Party

Ashraful Hoque

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ashraful Hoque, DBST

Role: PRINCIPAL_INVESTIGATOR

Sheikh Hasina National Institute of Burn & Plastic Surgery

Locations

SheikhHasinaNIBPS

Dhaka, , Bangladesh

Countries

Bangladesh

References

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Reference Type: RESULT

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Reference Type: RESULT

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Bhatt S, Gething PW, Brady OJ, Messina JP, Farlow AW, Moyes CL, Drake JM, Brownstein JS, Hoen AG, Sankoh O, Myers MF, George DB, Jaenisch T, Wint GR, Simmons CP, Scott TW, Farrar JJ, Hay SI. The global distribution and burden of dengue. Nature. 2013 Apr 25;496(7446):504-7. doi: 10.1038/nature12060. Epub 2013 Apr 7.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 25230594 (View on PubMed)

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Reference Type: RESULT

Other Identifiers

SHNIBPS: June2024/03

Identifier Type: -

Identifier Source: org_study_id