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CTRI Number  CTRI/2024/10/075174 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the effectiveness and safety of Injection (IM)Anti D for the management of low platelets in a patient of dengue fever in a tertiary care teaching hospital  
Scientific Title of Study   To evaluate the effectiveness and safety of IM Anti D for the management of thrombocytopenia in a patient of dengue fever in a tertiary care teaching hospital  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Smita Avhad 
Designation  Assistant Professor 
Affiliation  GMC&MPGIMER,MUHS Nashik 
Address  GMC&MPGIMER MUHS Nahik Department of Pharmacology room no 1 Civil Hospital Campus Trambak rd Nashik

Nashik
MAHARASHTRA
422002
India 
Phone  9763999856  
Fax    
Email  mbrsmita@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  DrSmita Avhad 
Designation  Assistant Professor 
Affiliation  GMC&MPGIMER,MUHS, Nashik 
Address  GMC & MPGIMER, MUHS, NASHIK Department of Pharmacology Civil Hospital Campus Trambak road

Nashik
MAHARASHTRA
422002
India 
Phone  9763999856  
Fax    
Email  mbrsmita@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr. Madhuri Kirloskar 
Designation  Associate Professor 
Affiliation  GMC&MPGIMER,MUHS, Nashik 
Address  GMC & MPGIMER, MUHS, Nashik Civil Hospital Campus, Trambak road


MAHARASHTRA
422002
India 
Phone  9822018284  
Fax    
Email  mbrsmita@yahoo.co.in  
 
Source of Monetary or Material Support  
GMC& MPGIMER, MUHS Nashik Civil Hospital Campus, Trambak rd, Nashik 422002 
 
Primary Sponsor  
Name  Dr Smita Avhad 
Address  GMC & MPGIMER, MUHS Nashik, Civil Hospital Campus Trambak rd Nashik 422002 
Type of Sponsor  Other [Principal Investigator (Self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Smita Avhad  CIVIL Hospital Nashik, Maharashtra  GMC&MPGIMER, MUHS Nashik, 422001
Nashik
MAHARASHTRA 		 9763999856

mbrsmita@yahoo.co.in 
Dr Smita Avhad  GMC& MPGIMER  CIVIL hospital Nasshik
Nashik
MAHARASHTRA 		 9763999856

mbrsmita@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC MPGIMER,MUHS Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B99-B99||Other infectious diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intramuscular Anti D  The product anti- D ( Rhoclone) will be given 300mcg IM inj in Rh+ non splenectomised patients along with standard treatment guideline. Day 0 ---- Day of Screening Day 1 ----Giving 1st dose of Anti D Day 2 ----Repeat Platelet count Day 3 ----Giving 2nd dose of Anti D Day 4 ----Repeat platelet count Day 5 ----Giving 3rd dose of Anti D Day 6 --- Repeat platelet count  
Comparator Agent  Standard Treatment guideline for thrombocytopenia in dengue  Standard Treatment guideline for thrombocytopenia in dengue. Symptomatic & supportive Bed rest, Cold sponging to keep temperature below 39 oC Paracetamol 10mg/KG Body Weight per dose which can be repeated at the interval of 6hrs Oral fluid and electrolyte therapy are recommended for patients with excessive sweating or vomiting. Monitored for DHF  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Rh+ patients , non-splenectomy with serology proven dengue positivity, thrombocytopenia14 (platelet count 50,000-90,000/mm3 
 
ExclusionCriteria 
Details  1. DHF15patients/DSS patient
2. Dengue patients with platelet count ≥90,000/mm3, Rh−, and pregnant females, and teenagers below 18yrs , patients with bleeding tendencies & coagulation disorders, patients on anticoagulants , patients on NSAIDs, or any other drug which might interfere with platelets ,Hb less than 8g/dl, patient will be excluded from the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A sample size of subjects 46 (23 in each group) is estimated using platelet count at 48 hours of dengue patients, at 95% confidence interval 80% power and a 5% level of significance. By considering 10% attrition rate the final sample size will be 50 (25 per group)
Therefore, we will include at least 50 (25 per group) dengue patients in this study.
-value less than 5% will be consider statistically significant.  		 Day 1 or Day 3 or Day 5 of the recruitment schedule.
This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening 
 
Secondary Outcome  
Outcome  TimePoints 
To see the platelet rise after the first dose of anti d, or the second or the third, same as primary outcome  Day 1 or Day 3 or Day 5 of the recruitment schedule.
This will be assessed after 1st/2nd/3rd dose of Injection Anti D wherein we get a rise in platelet count more than 20 percent above the baseline value which is at the day of screening  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   25/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mbrsmita@yahoo.co.in].

  6. For how long will this data be available start date provided 31-07-2024 and end date provided 31-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Dengue is vector-borne disease. Though self limiting , it can have a phase of critical defervescence. Thrombocytopenia and platelet dysfunction are common and are related to clinical outcomes.

Efficacy of empirical and therapeutic platelet transfusion is not proven in DHF/DSS patients with severe thrombocytopenia without bleeding manifestations .Intravenous Anti D has been successfully used in ITP7 . It also seems to  be an effective, promising therapy in Rh+ DHF with severe thrombocytopenia.

Okwundu C I et.al have compared the efficacy and effectiveness of IM versus IV anti-D IgG in preventing RhD alloimmunization in RhD-negative pregnant women  and were found to be equally effective.

 (Okwundu CI, Afolabi BB. Intramuscular versus intravenous anti‐D for preventing Rhesus alloimmunization during pregnancy. Cochrane Database of Systematic Reviews. 2013)

On this basis, we suggest use of intramuscular Anti D in Dengue associated thrombocytopenia which will bridge the existing gap in terms of effectiveness, cost and availability.

 

 
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