CTRI/2025/08/092847 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On:
11/08/2025
Post Graduate Thesis
Yes
Type of Trial
Observational
Type of Study
Cohort Study
Study Design
Other
Public Title of Study
Comparison between six different machines used for collecting platelets from donors.
Scientific Title of Study
A comparative study of six automated cell separators for plateletpheresis in a tertiary care cancer hospital of India.
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 Akshay Batra
Designation
Associate Professor of Transfusion Medicine
Affiliation
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India
Address
Department of Immunohematology and Blood Transfusion
Homi Bhabha Cancer Hospital
Ghanti Mill Road
Shivpurwa
Lahartara
DRM Office SO
Varanasi Cantt
Varanasi UTTAR PRADESH 221002 India
Phone
05426917700
Fax
Email
akshay@mpmmcc.tmc.gov.in
Details of Contact Person Scientific Query
Name
Dr Akshay Batra
Designation
Associate Professor of Transfusion Medicine
Affiliation
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India
Address
Department of Immunohematology and Blood Transfusion
Homi Bhabha Cancer Hospital
Ghanti Mill Road
Shivpurwa
Lahartara
DRM Office SO
Varanasi Cantt
Varanasi UTTAR PRADESH 221002 India
Phone
05426917700
Fax
Email
akshay@mpmmcc.tmc.gov.in
Details of Contact Person Public Query
Name
Dr Akshay Batra
Designation
Associate Professor of Transfusion Medicine
Affiliation
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India
Address
Department of Immunohematology and Blood Transfusion
Homi Bhabha Cancer Hospital
Ghanti Mill Road
Shivpurwa
Lahartara
DRM Office SO
Varanasi Cantt
UTTAR PRADESH 221002 India
Phone
05426917700
Fax
Email
akshay@mpmmcc.tmc.gov.in
Source of Monetary or Material Support
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Varanasi
Tata Memorial Centre Research Administration Council (TRAC), Tata Memorial Hospital, Mumbai
Primary Sponsor
Name
Dr Akshay Batra
Address
Dr Akshay Batra, Associate Professor, Department of Immunohematology and Blood Transfusion, Blood Centre, Second Floor, Homi Bhabha Cancer Hospital, Lahartara, DRM Office SO, Varanasi Cantt, Varanasi PIN 221002 Uttar Pradesh
Type of Sponsor
Research institution and hospital
Details of Secondary Sponsor
Name
Address
NIL
NA
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Akshay Batra
Homi Bhabha Cancer Hospital Varanasi
Third Floor
Blood Centre
Department of Immunohematology and Blood Transfusion
Homi Bhabha Cancer Hospital
Lahartara
DRM Office SO
Near NER Divisional Railway Hospital
Varanasi Cantt Varanasi UTTAR PRADESH
8009976667
akshay@mpmmcc.tmc.gov.in
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee MPMMCC HBCH
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Voluntary Platelet Donors donating platelets via plateletpheresis
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Intervention
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1. Donors shall be in good health, mentally alert and physically fit and shall not be inmates of jail or any other confinement.
2. Age of the Donor – minimum 18 years; maximum 60 years.
3. Weight of the Donor – 55 kg and above.
4. Donors shall have at least one prominent vein, preferably two, for easy venous access.
5. Donors who are found medically acceptable according to the Departmental Standard Operating Procedure (following the General Statutory Rules (GSR) 166(E) of 2020, and 2025 Guidelines for Blood Donor Selection and Blood Donor Referral by National Blood Transfusion Council).
6. Donors consenting to participate in the study.
7. Donors shall have at least one prominent vein, in either cubital fossa, for easy venous access.
8. Donors who donated a minimum target yield of 300 billion platelets per bag.
9. Donors from whom a post-donation sample was taken.
ExclusionCriteria
Details
1. Donor had donated platelets via apheresis within the last 48 hours.
2. Donor has donated platelets via apheresis more than 2 times in a week.
3. Donor had donated platelets via apheresis more than 24 times in a year.
4. Donation of Whole Blood within the last 7 days.
5. Reinfusion of red cells not complete during the last procedure of apheresis, done within 90 days.
6. Donor bone marrow harvest done within 12 months.
7. Donor peripheral stem cell harvest done within 6 months.
8. Blood pressure of the donor is less than 100 by 60 mmHg, or more than 140 by 90 mm Hg, with or without medications.
9. Findings in donors suggestive of end organ damage or secondary complications (cardiac, renal, eye or vascular) or history of feeling giddiness, fainting made out during history and examination.
10. Donor hearts beat less than 60, or more than 100 per minute; irregular in nature.
11. Febrile donor – temperature more than 370C.
12. Acute respiratory disease.
13. Hemoglobin less than 12.5 g per dL.
14. Platelets count less than 150 thousand per mL.
15. Last meal took more than 4 hours prior to donation.
16. Consumed alcohol and intoxicated.
17. As far as can be determined by history and examination, the donor is suspected of suffering from some disease transmissible by blood transfusion.
18. Skin diseases at the site of phlebotomy, skin punctures or needle scars indicative of addiction.
19. Donor suffering from general malaise, pain, headache.
20. Donor suffering from cold, flu, cough, sore throat or acute sinusitis.
21. Asthmatic donor.
22. Pregnancy or recently delivered donor in the last 12 months.
23. Donor who had abortion in the last 6 months.
24. Donor who is breastfeeding.
25. Donor who is menstruating.
26. Donor had major surgery in the last 12 months.
27. Donor had minor surgery in the last 3 months.
28. Donor who had open-heart surgery, by-pass surgery, and cancer surgery.
29. Donor who had tooth-extraction or dental surgery under anesthesia within the last 6 months, any other dental procedure within the last 3 days.
30. Donor who have structural or functional heart disease.
31. Migraine with frequency of more than one episode per week.
32. Donor with severe anxiety or mood disorder, not controlled by medications.
33. Donor with convulsions, epilepsy, or schizophrenia.
34. Donor with uncontrolled diabetes.
35. Donor on regular insulin for diabetes.
36. Donor with Hyper- or Hypo-Thyroidism, and Thyrotoxicosis.
37. Donor with unknown hepatitis, known Hepatitis B and C infection.
38. Donor with Hepatitis A or E in the last 12 months.
39. Donor is spouse/ partner/ close contact for the last 12 months, of an individual suffering with hepatitis.
40. Donors who had tattoos, acupuncture or body piercing, scarification and any other invasive cosmetic procedure within the last 12 months.
41. Donor is the spouse or partner of an individual who had received transfusion of blood or components in the last 12 months.
42. Donor with history of jaundice not attributed to gallstones, Rh disease, mononucleosis or neonatal period.
43. Donor who had worked in renal dialysis in the last 12 months.
44. Donor who had received blood or component transfusion in the last 12 months.
45. Donor who is at risk of HIV infection (Transgender, Men who have Sex with Men, Female Sex Workers, Injecting drug users, persons with multiple sex partners).
46. Known HIV positive donor or spouse or partner of PLHA (person living with HIV AIDS).
47. Donor having symptoms suggestive of AIDS.
48. Donor with syphilis or gonorrhoea.
49. Donor who has recovered from measles, mumps, chickenpox within the last 2 weeks.
50. Donor who has recovered from malaria within the last 3 months.
51. Donor who has recovered from typhoid within the last 12 months.
52. Donor who has recovered from dengue or chikungunya within the last 6 months.
53. Donor who has recovered from Zika or West Nile virus within the last 4 months.
54. Donor who is cured from tuberculosis within the last 2 years.
55. Donor with Leishmaniasis or Leprosy.
56. Donor with untreated conjunctivitis.
57. Donor who is cured from osteomyelitis within the last 2 years.
58. Donor who has recovered from acute kidney infection within the last 6 months.
59. Donor who has recovered from acute bladder infection within the last 2 weeks.
60. Donor who has chronic kidney disease.
61. Donor who has recovered from diarrhoea with fever within the last 2 weeks.
62. Donor who had GI Endoscopy within the last 12 months.
63. Donor with symptomatic peptic ulcer at risk of bleeding.
64. Donors with autoimmune disorders like systemic lupus erythematosis, scleroderma, dermatomyositis, ankylosing spondylitis or severe rheumatoid arthritis.
65. Donor with polycythaemia vera, bleeding disorders and unexplained bleeding tendency.
66. Donor with malignancy.
67. Donor with severe allergic disorder.
68. Donors who have been injected with non-live vaccines and toxoids, including Covaxin, in the last 14 days.
69. Donors who have been injected with live attenuated vaccines, including Covishield in the last 28 days.
70. Donors who have been injected with anti-tetanus serum or anti-venom serum in the last 28 days.
71. Donors who have been injected with anti-rabies vaccination, Hepatitis B, or any other Immunoglobulin in the last 1 year.
72. Donor on aspirin or any other NSAIDs for the last 3 days.
73. Donors who have recovered from illness after taking antibiotics in the last 2 weeks.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Procedural Variables (Procedure Duration, Total Blood Volume (TBV) Processed, Collection Efficiency, and Collection Rate; Total Anticoagulant used, Anticoagulant infused to Donor)
2. Procedural Efficiency (Frequency and Nature of Errors, and Procedure Abortions)
3. Quality Parameters of SDP Conc. include the following (Visual Check, Swirling, Volume, Product Yield, RBC count, WBC count, pH).
Baseline Data collected On the Day of Plateletpheresis Procedure (defined as Day 0) - Data for "Outcome 1." Procedural Variables, and "Outcome 2." Procedural Efficiency.
On the Next Day (defined as Day 1), Data for "Outcome 3." Quality Parameters of SDP Conc. will be collected.
Secondary Outcome
Outcome
TimePoints
4. Donor satisfaction with the plateletpheresis procedure on each cell separator shall be evaluated using a structured questionnaire.
At Baseline, immediately after the plateletpheresis procedure.
5. Incidence & type of donor adverse effects shall be documented using Donor Reaction Form (DRF, as approved & released by the National Institute of Biologicals (NIB), Government of India).
At Baseline, during or immediately after the plateletpheresis procedure.
Target Sample Size
Total Sample Size="936" Sample Size from India="936" 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)
01/09/2025
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="6" 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 - YES
What data in particular will be shared? Response - All of the individual participant data collected during the trial, after de-identification.
What additional supporting information will be shared? Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response - Proposals should be directed to [akshay@mpmmcc.tmc.gov.in].
For how long will this data be available start date provided 01-09-2025 and end date provided 31-08-2030? Response (Others) - Immediately following publication and ending 5 years following recruitment of first participant.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - IPD sharing, under any circumstance, will not be done in contravention to Drugs and Cosmetics Act 1940 (and Rules 1945) and its Future Ammendements thereof, pertaining to Blood and Blood Products.
Brief Summary
Summary of the Plateletpheresis Platform Comparison Study
This prospective observational study aims to compare six different automated cell separators—Amicus, AmiCORE, COM.TEC, Haemonetics MCS plus, Spectra Optia, and Trima Accel—based on their performance in plateletpheresis procedures, donor experience, and quality of the single donor platelet concentrate (SDPC) products. The study will be conducted at the Homi Bhabha Cancer Hospital Blood Centre, Varanasi, and will include healthy voluntary platelet donors from Varanasi and adjoining districts of Uttar Pradesh, India.
Hypothesis
Among various automated cell separators, while collecting platelets via apheresis technique, the technical parameters will be identical, the feedback of donors will be similar, the rate of adverse effects will be the same, and the quality parameters of collected single donor platelet concentrate will be analogous (H0).
Day 0: Donor Recruitment and Plateletpheresis
Prospective donors will register at the Blood Centre, undergo standard eligibility screening, and provide informed written consent. Those consenting will be randomized to one of the six apheresis platforms. Baseline donor characteristics—age, gender, height, weight—will be documented, and Total Blood Volume (TBV) and Body Surface Area (BSA) will be calculated using standard formulas. Pre-procedural hematologic parameters (CBC) will be measured.
After randomization, donors will receive calcium carbonate (500 mg elemental calcium) to prevent citrate toxicity. Plateletpheresis will be conducted as per the department’s SOP. Procedure-related variables including duration, total anticoagulant used, anticoagulant infused to the donor, blood volume processed (BVP), and calculated total blood volume processed (TBVP) will be recorded. Procedure efficiency (errors or abortions) and donor adverse events (e.g., vasovagal reactions, citrate toxicity, hematoma) will also be tracked.
Post-procedure, another CBC will be performed. Donors will then complete a 10-item structured feedback survey rated on a 5-point Likert scale, assessing their satisfaction and experience. The total score (range 10–50) will reflect the overall donor satisfaction.
Day 1: Quality Control of SDPC
On the following day, quality control testing of the collected SDPC will be conducted. Samples from the SDPC will be tested for platelet, RBC, and WBC counts. Additional parameters like volume, pH (via potentiometry), and swirling (graded visually) will be assessed. Platelet yield will be calculated, and collection efficiency (CE) and collection rate (CR) derived using standard formulas.
Data Management and Statistical Analysis
All data will be recorded in a structured Case Record Form (CRF), including donor demographics, lab parameters, procedural variables, product quality, donor adverse effects, and feedback scores. Descriptive statistics will be used to summarize the data. One-way ANOVA or Kruskal-Wallis test will compare continuous variables; Chi-square test will be used for categorical data. Regression analysis will adjust for confounders, and mixed-effects models will address operator-level or repeated measure variability. A p-value <0.05 will be considered statistically significant.
Ethics and Confidentiality
The study has ethical approval and ensures confidentiality per regulatory norms. Donors may withdraw consent at any point without any obligation. Access to data is restricted to the principal and co-investigators.
Implications
The study will help determine the most efficient and donor-friendly apheresis platform in terms of yield, product quality, safety, and satisfaction. The findings will guide device selection, SOP development, staff training, and regulatory compliance in transfusion services, especially in oncology care settings.