Platelet recovery in donors after double dose platelet donatio

Not Applicable

• Registration Number: CTRI/2024/03/064778
• Lead Sponsor: RELIABLE CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified