| CTRI Number |
CTRI/2024/07/070375 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of age of blood donor on outcome in Intensive Care Unit patients |
|
Scientific Title of Study
|
Effect of blood donor age on recipient outcome in patients admitted in Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukrit Kaur Janjua |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Department of Transfusion Medicine, Government Medical College and Hospital, Chandigarh |
| Address |
Department of Transfusion Medicine, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
01722502210 |
| Fax |
01722502210 |
| Email |
sukritjanjua@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kshitija Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Department of Transfusion Medicine, Government Medical College and Hospital, Chandigarh |
| Address |
Department of Transfusion Medicine, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
01722502210 |
| Fax |
|
| Email |
drkmittal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshitija Mittal |
| Designation |
Assistant Professor |
| Affiliation |
Department of Transfusion Medicine, Government Medical College and Hospital, Chandigarh |
| Address |
Department of Transfusion Medicine, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
01722502210 |
| Fax |
|
| Email |
drkmittal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Transfusion Medicine, Government Medical College and Hospital, Sector 32, Chandigarh, India. Pin Code - 160030. |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Department of Transfusion Medicine Government Medical College and Hospital Sector 32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 Kshitija Mittal |
Government Medical College and Hospital, Chandigarh |
Room no 254, Department of Transfusion Medicine, Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH |
9814853110
drkmittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male donors 18-65 years of age |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transfusion of packed red blood cells prepared from donors 18-24 years of age. |
Group I - PRBCs prepared from donors 18-24 years of age.
|
| Comparator Agent |
Transfusion of packed red blood cells prepared from donors 25-45 years of age. |
Group II - PRBCs prepared from donors 25-45 years of age. |
| Comparator Agent |
Transfusion of packed red blood cells prepared from donors 46-65 years of age. |
Group III- PRBCs prepared from donors 46-65 years of age. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male blood donors in the age group of 18-65 years and meeting all other criteria for whole blood donation as per guidelines laid by Drug Controller General of India (DCGI).
PRBCs less than 14 days old
Patients admitted to multidisciplinary ICU
Patients age more than 18 years
Expected duration of ICU stay more than 48 hours
APACHE II score between 10 – 20 |
|
| ExclusionCriteria |
| Details |
Female blood donors , Blood donors where blood is collected in double or quadruple blood bags, Under collected/over collected bags, Blood donors reactive for any transfusion transmitted infections (TTI), Technical errors during component preparation, Cardiac diseases, Rare blood groups and Patients with pre-existing alloantibodies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Length of stay in hospital & ICU
2. Need for hemodynamic support
3. Need for mechanical ventilation
4. Adverse transfusion reaction
5. Clinically accepted measures of multiple organ dysfunction
|
Every 7 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 Applicable |
| 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
|
The hemoglobin increment in patients following packed red cell transfusions is reported to be 1 gm/dl. However, donor characteristics may also influence the increment as reported in the literature. The present study is planned to see the effect of blood donor age on patient outcomes following packed red cell transfusions in patients admitted to the intensive care unit.
|