None listed
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
RELIABLE CORPORATION
Eligibility
Inclusion criteria
Inclusion criteria: Donors who fulfil the plateletpheresis donor eligibility criteria laid down by Drugs and Cosmetic (second amendment) Rule, 2020 and consent to participate in the study 1. Age- 18-60 years 2. Weight of donor- 50 kgs and more (3) 3. Blood pressure-100 to 140 mm Hg systolic, 60 to 90 mm Hg diastolic with or without medication. 4. Pulse-60- 100/min 5. Temperature- Afebrile; 370C or 98.40F 6. Haemoglobin- 12.5 g/dl and more 7. Platelet count- 150,000/ul and more (3) 8. Donation interval- Between procedures should be at least 48 hours. A donor should not undergo the procedure more than 2 times a week or 24 times a year. After the whole blood donation plateletpheresis, the donor should be accepted only after 28 days of interval. 9. Skin- Free from any skin disease 10. Transfusion transmitted infections- Nonreactive status However, for Double dose plateletpheresis procedure (DDP), the donors should fulfil the additional criteria according to Directorate General of Health Services (DGHS) 3rd edition 2022: (12) 1.Weight of the donor should be > 60 kgs, 2. Platelet count > 250 x 1011/ul, 3. Not a first-time donor, 4. Interval between two plateletpheresis procedure- at least 1 month (according to Departmental SOP)
Exclusion criteria
Exclusion criteria: Donors who do not fulfil the plateletpheresis donor criteria laid down by the Drugs and Cosmetics (Second amendment) rules, 2020 (9) and not consent to participate in the study will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To calculate and compare the Recruitment Factor (RF) in Double Dose plateletpheresis donor across two different cell separators.Timepoint: 6 months Base line and pre-procedure CBC will be done on the day of procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare collection efficiencies (CE) and collection rates (CR) in Double Dose Plateletpheresis (DDP) procedure across two cell separators. 2. To assess the platelet yield of Single Donor Platelets (SDP) prepared from Double Dose Platelets product. 3. To analyze the adverse donor reactions in Double Dose Plateletpheresis donors if any. 4. To compare pre and post procedure hematological parameters of the double dose plateletpheresis (DDP) donors. Timepoint: 6 Months | — |
Countries
India
Contacts
Public ContactDr Salamma Bodagala
Tata Memorial Centre
Outcome results
None listed