A study to determine the effectiveness of oral calcium supplementation in terms of best suitable dose and schedule to prevent citrate related adverse reactions in Single Donor Apheresis Platelet donors.
Phase 2
- Registration Number
- CTRI/2022/08/044856
- Lead Sponsor
- AIIMS Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Donors eligible for plateletphersis as per the Drugs and Cosmetics Act 1940; Rule 1945 (Amendment 2020) (DCA)
Exclusion Criteria
i.Donors eligible as per the DCA but found to be reactive in transfusion transmitted infectious disease screening testing
ii.Donors already on calcium, or Vitamin D supplements.
iii.Donors with incomplete procedure due to reason other than hypocalcemic adverse reactions.
iv.Donors with incomplete procedure due to technical reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in the biochemical parameters: ionized calcium and magnesium, total calcium, vitamin D, parathormone (PTH), serum albumin levelTimepoint: They will be measured first immediately before providing calcium supplementation or immediately before starting the procedure (whichever is earlier) and second 15 minutes after completion of the procedure or at the time of additional calcium supplementation if required due to in-procedure adverse citrate reaction (whichever is earlier).
- Secondary Outcome Measures
Name Time Method Changes in donor�s complete blood count (Hemoglobin, hematocrit, platelet count, mean platelet volume, reticulocyte hemoglobin and immature platelet fraction) and coagulation parameters (prothrombin time [PT] and activated partial thromboplastin time [aPTT])Timepoint: Before starting the procedure and 15 minutes after completion of the procedure.;Incidence of donor adverse reactionsTimepoint: Adverse reactions will be monitored throughout the procedure and till the 15 minutes after completion of the procedure.