Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients (EFFP-TDP)
Efficacy of Fresh Frozen Plasma (Ffp) in the Treatment of Thrombocytopenia in Dengue Patients
Study Overview
Status
Intervention / Treatment
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:
- Assess the effect of plasma transfusion on aPTT in non-bleeding thrombocytopenic dengue patients.
- Evaluate the clinical outcomes, including the incidence of bleeding complications, in patients receiving plasma transfusion.
- Determine the safety and feasibility of plasma transfusion in this patient population.
- Measure changes in other coagulation parameters such as prothrombin time (PT) and fibrinogen levels post-transfusion.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1205
- SheikhHasinaNIBPS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
Intervention Type: Biological
|
|
Placebo Comparator: 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. |
Intervention Type: Biological
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
Time Frame: 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.
|
24 to 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: 30 days
|
This outcome tracks hospitalized patients' minor and significant bleeding occurrences.
Clinical severity will classify bleeding occurrences (e.g., petechiae, mucosal, gastrointestinal).
Staff will collect data everyday through clinical assessments and record it in patient records.
The experimental (FFP + standard care) and control (standard care alone) groups will be compared for bleeding problems.
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ashraful Hoque, DBST, Sheikh Hasina National Institute of Burn & Plastic Surgery
Publications and helpful links
General Publications
- undefined
- Lye DC, Lee VJ, Sun Y, Leo YS. Lack of efficacy of prophylactic platelet transfusion for severe thrombocytopenia in adults with acute uncomplicated dengue infection. Clin Infect Dis. 2009 May 1;48(9):1262-5. doi: 10.1086/597773.
- Wills BA, Oragui EE, Dung NM, Loan HT, Chau NV, Farrar JJ, Levin M. Size and charge characteristics of the protein leak in dengue shock syndrome. J Infect Dis. 2004 Aug 15;190(4):810-8. doi: 10.1086/422754. Epub 2004 Jul 19.
- Malavige GN, Velathanthiri VG, Wijewickrama ES, Fernando S, Jayaratne SD, Aaskov J, Seneviratne SL. Patterns of disease among adults hospitalized with dengue infections. QJM. 2006 May;99(5):299-305. doi: 10.1093/qjmed/hcl039. Epub 2006 Apr 7.
- Martina BE, Koraka P, Osterhaus AD. Dengue virus pathogenesis: an integrated view. Clin Microbiol Rev. 2009 Oct;22(4):564-81. doi: 10.1128/CMR.00035-09.
- Mackenzie JS, Gubler DJ, Petersen LR. Emerging flaviviruses: the spread and resurgence of Japanese encephalitis, West Nile and dengue viruses. Nat Med. 2004 Dec;10(12 Suppl):S98-109. doi: 10.1038/nm1144.
- 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.
- Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Wounds and Injuries
- Hematologic Diseases
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Blood Platelet Disorders
- Body Temperature Changes
- Heat Stress Disorders
- Cytopenia
- Mosquito-Borne Diseases
- Shock
- Hyperthermia
- Fever
- Thrombocytopenia
- Hemorrhagic Fevers, Viral
- Dengue
- Severe Dengue
Other Study ID Numbers
- SHNIBPS: June2024/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Access to de-identified individual participant data (IPD) will be granted to researchers who meet the following criteria:
Scientifically Sound Proposal: Researchers must submit a valid scientific proposal outlining the objectives and methodology, subject to review by the study's steering committee.
Ethics Approval: A valid ethics committee or IRB approval for secondary use of the data must be provided.
Data Use Agreement (DUA): Researchers must sign a DUA ensuring data use is limited to approved purposes, maintains participant privacy, and follows data security measures.
Non-commercial Use: Data access is limited to academic and public health research, not for commercial purposes.
Publication: Researchers agree to publish their findings in peer-reviewed journals or other public formats.
Security: Data must be handled in compliance with relevant privacy regulations.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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