Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642493
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Efficacy of Fresh Frozen Plasma FFP in Treating Thrombocytopenia in Dengue Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Fresh Frozen Plasma Ffp in the Treatment of Thrombocytopenia in Dengue Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFFP-TDP
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 50000μL 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 mLkg 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 005 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
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 50000μL 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 mLkg 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 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None