Dengue FeverEFFP-TDPNCT06642493
Efficacy of Fresh Frozen Plasma (FFP) in Treating Thrombocytopenia in Dengue Patients
A study testing Fresh frozen plasma in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sheikh Hasina National Institute of Burn and Plastic Surgery at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dengue Fever, Dengue Hemorrhagic Fever, Dengue Shock Syndrome
- What is being tested?
- Fresh frozen plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with dengue fever, thrombocytopenia (platelet count \< 100,000/μL), and elevated aPTT (\> 40 seconds) without active bleeding.
Who cannot join
- Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Fresh Frozen Plasma (Ffp) in the Treatment of Thrombocytopenia in Dengue Patients
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.
Read the 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.
- Being tested
- Fresh frozen plasma
- Keywords
- Dengue fever, Thrombocytopenia, Plasma transfusion, Elevated aPTT, Coagulopathy in dengue, Non-bleeding dengue complications, Hemostatic management in dengue
- Medical subject headings
- Dengue, Severe Dengue, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh frozen plasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Intervention Arm Title: Plasma Transfusion. | Experimental | 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. Receives: Biological: Fresh frozen plasma |
| Arm 2: Control Arm Title: Standard Supportive Care | Placebo comparator | 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. Receives: Biological: Fresh frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in aPTT values from baseline to 24 and 48 hours post-transfusion.
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.
Measured: 24 to 48 hours
Secondary outcomes (1)
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
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 May 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dengue FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Hasina National Institute of Burn and Plastic Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraful Hoque, Sheikh Hasina National Institute of Burn and Plastic Surgery
- Investigators
- Ashraful Hoque, DBST, Principal investigator, Sheikh Hasina National Institute of Burn & Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642493
- Sponsor's protocol ID
- SHNIBPS: June2024/03
- Acronym
- EFFP-TDP
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers will have access to the de-identified individual participant data (IPD) that was collected during this trial upon a reasonable request. Individual participant data on baseline characteristics, primary and secondary outcome measures, and adverse event reports will comprise the shared data.
Publications
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.
PubMed 19292665Wills 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.
PubMed 15272410Malavige 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.
PubMed 16603571Martina 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.
PubMed 19822889Mackenzie 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.
PubMed 15577938Bhatt 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.
PubMed 23563266Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.
PubMed 25230594undefined
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fresh Frozen Plasma (Ffp) in the Treatment of Thrombocytopenia in Dengue Patients
- ClinicalTrials.gov ID
- NCT06642493
- Acronym / sponsor ID
- EFFP-TDP / SHNIBPS: June2024/03
- Keywords
- Dengue fever, Thrombocytopenia, Plasma transfusion, Elevated aPTT, Coagulopathy in dengue, Non-bleeding dengue complications, Hemostatic management in dengue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sheikh Hasina National Institute of Burn and Plastic SurgeryUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention Arm Title: Plasma Transfusion. | Experimental | Biological: Fresh frozen plasmaArm 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. |
| Arm 2: Control Arm Title: Standard Supportive Care | Placebo comparator | Biological: Fresh frozen plasmaArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with dengue fever, thrombocytopenia (platelet count \< 100,000/μL), and elevated aPTT (\> 40 seconds) without active bleeding.
Key exclusion criteria (1 listed)
- Patients with active bleeding, known coagulopathies unrelated to dengue, or contraindications to plasma transfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fresh frozen plasmaIntervention 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. | Biological | Arm 1: Intervention Arm Title: Plasma Transfusion., Arm 2: Control Arm Title: Standard Supportive Care |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 19292665Lye 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.
- Results publication: PubMed 15272410Wills 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.
- Results publication: PubMed 16603571Malavige 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.
- Results publication: PubMed 19822889Martina 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.
- Results publication: PubMed 15577938Mackenzie 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.
- Results publication: PubMed 23563266Bhatt 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.
- Results publication: PubMed 25230594Guzman MG, Harris E. Dengue. Lancet. 2015 Jan 31;385(9966):453-65. doi: 10.1016/S0140-6736(14)60572-9. Epub 2014 Sep 14.
- Results publicationundefined
- Individual participant dataSharing planned: Yes. The researchers will have access to the de-identified individual participant data (IPD) that was collected during this trial upon a reasonable request. Individual participant data on baseline characteristics, primary and secondary outcome measures, and adverse event reports will comprise the shared data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraful Hoque, DBST principal investigator
Sheikh Hasina National Institute of Burn & Plastic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh frozen plasma in people with Dengue Fever and Dengue Hemorrhagic Fever, run by Sheikh Hasina National Institute of Burn and Plastic Surgery at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in aPTT values from baseline to 24 and 48 hours post-transfusion. (time frame: 24 to 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06642493, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.