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.

A randomized control trial to determine the efficacy and schedule of oral calcium supplementation for prevention of adverse citrate reaction in plateletpheresis donors.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/08/044856

Enrollment

280

Registered

2022-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Oral calcium carbonate tablets: Donors will be divided into 7 groups where either they will fall in the control group and receive no prophylaxis or they will fall in any of the other si

Eligibility

Inclusion criteria

Inclusion criteria: Donors eligible for plateletphersis as per the Drugs and Cosmetics Act 1940; Rule 1945 (Amendment 2020) (DCA)

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
Changes in donorÃ¢â?¬â?¢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.	—

Measure

Time frame

Changes in donorÃ¢â?¬â?¢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.

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Countries

India

Contacts

Public ContactDr Shruti Rohilla

All India Institute of Medical Sciences, New Delhi

drgpatidar@gmail.com9781089405

Outcome results