| 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
|
|
|
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
|
|
|
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. |