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临床试验/CTRI/2024/03/064778
CTRI/2024/03/064778尚未招募Unknown

Platelet recruitment in donors undergoing double dose plateletpheresis procedure - NI

RELIABLE CORPORATIO0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 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)

排除标准

  • 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.

研究者

发起方
RELIABLE CORPORATIO

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