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CTRI Number  CTRI/2024/09/074111 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 17/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of blood clotting ability of frozen platelets in trauma patients against the standard platelet transfusion 
Scientific Title of Study   Hemostatic evaluation of cryopreserved platelets concentrates compared to the room temperature stored platelet concentrates in trauma patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  RAHUL CHAURASIA 
Designation  Additional Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room number 215, Jai Prakash Narayan Apex Trauma center, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  919560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAHUL CHAURASIA 
Designation  Additional Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room number 215, Jai Prakash Narayan Apex Trauma center, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  919560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RAHUL CHAURASIA 
Designation  Additional Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room number 215, Jai Prakash Narayan Apex Trauma center, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  919560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Source of Monetary or Material Support  
Intramural collaborative research project, Research section, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  Intramural collaborative research project, Research section, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAHUL CHAURASIA  Jai Prakash Narayan Apex Trauma center, AIIMS  Department Of Transfusion Medicine, Room No. 214, Blood center, JPNATC
New Delhi
DELHI 
9560345917

drrahulchaurasia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITIONAL ETHICS COMMITTEE, AIIMS, NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cryopreserved platelet concentrates  pooled platelet concentrates (200ML) will be treated with cryoprotective agent (Di-methyl sufoxide, 5-6 % v/v), after proper mixing, platelet concentrate shall be centrifuged to remove the excess DMSO and supernatant plasma, this will be followed by freezing at -80C, and after storage for 72 hours, it will be thawed at 37C, and reconstituted using AB group plasma and then used for transfusion to eligible patient group 
Comparator Agent  standard platelet transfusion (pool of 4 platelets)  transfusion of standard room temperature stored platelets 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  adult patients (18 years or more), both male and females, platelet transfusion are indicated, hemodynamically stable patients, platelet counts less than or equal to 50000/ul, bot PT and aPTT tests have values less than or equal to 1.5 times the normal value 
 
ExclusionCriteria 
Details  presence of active/frank bleeding, head injury patients, patients with genetic bleeding disorders, patients unable to consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in MAXIMUM CLOT FIRMNESS (MCF) on ROTEM parameters (viscoelastic testing) from pre-transfusion levels   at 1-2 hours after platelet transfusion 
 
Secondary Outcome  
Outcome  TimePoints 
change in platelet counts before and after transfusion of platelet component  1-2 hours and 18-24 hours 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
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 - NO
Brief Summary  

Platelet concentrates (PC) are essential for the haemostatic management and prevention of bleeding in trauma patients PCs intended for transfusion are stored in the blood centre at room temperature (RT), with total shelf life of 5 days. The limited storage duration for the PC results in uneven inventory which on one-hand may lead to shortage during increased requirement or can result in increased wastage due to outdating PC. Cryopreservation of surplus whole blood-derived PC using dimethyl sulfoxide (DMSO) offers a promising solution to this problem, by extending the shelf life up to 2 years. This can be especially useful during trauma, war, disasters, seasonal epidemics (such as dengue), etc.  

Although, several in-vivo studies have been conducted to assess its safety and efficacy and has been shown to be non-inferior to fresh PC. As result of which many countries have adopted use of cryopreserved platelets for clinical use. Since, no studies have been conducted in the Indian context, where the shelf life of PC is limited to 5 days. We intend to evaluate the morphology, number and function of the cryopreserved platelets using cellular indices, flowcytometric markers for its activation and thromboelastometric response, following its transfusion in thrombocytopenic trauma patients.  

Dept of transfusion medicine: PC shall be prepared from whole blood collected from blood donors. Surplus PCs will then be pooled together on day 4 of storage, followed by splitting into equal halves to ensure that the control and intervention group are similar in terms of baseline platelet counts, sterility and platelet activation markers, measured using flowcytometry. After this the control group will be stored and issued as per the current standards. Simultaneously the PC in the intervention group, will be treated with DMSO (to achieve final concentration of 5-6% DMSO) under aseptic conditions. The procedure will be performed under strict aseptic conditions and in accordance with the protocols published in the literature. These DMSO treated PC will be stored at -80C for a minimum of 72 hours. After this the DMSO treated PC will be thawed and evaluated for the platelet counts, sterility and platelet activation markers, measured using flowcytometry. This will help us in establishing the in-vitro platelet recovery and the function of the cryopreserved platelets. 

Dept of surgery and Dept of critical and intensive care: Adult trauma patients who are hemodynamically stable and require platelet transfusion prophylactically, will be enrolled in the study groups (control and intervention) after taking informed consent. A baseline sample for complete blood counts, coagulation assays, and platelet function assays (thromboelastometry) will be done, prior to PC transfusion. After transfusion (1-2 hours), the same tests (complete blood counts, coagulation assays, and platelet function assays) will be performed to evaluate the response to to the platelet transfusions. After transfusion of PCs, patients will be actively monitored next 48 hours, for any adverse reactions associated with the transfusion and any additional need for platelet transfusion will be evaluated. This will help us in establishing the in-vivo haemostatic response to the platelet transfusions. 

 
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