None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Dr Akshay Batra
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).Timepoint: 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
| Measure | Time frame |
|---|---|
| 4. Donor satisfaction with the plateletpheresis procedure on each cell separator shall be evaluated using a structured questionnaire.Timepoint: 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).Timepoint: At Baseline, during or immediately after the plateletpheresis procedure. | — |
Countries
India
Contacts
Public ContactDr Akshay Batra
Homi Bhabha Cancer Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Varanasi, India
Outcome results
None listed