Reducing intravenous calcium administration during peripheral blood stem cell collection in healthy donors: the STEP-Ca study

Safety and feasibility of a de-escalation strategy for intravenous calcium administration during peripheral blood stem cell collection in healthy donors: a prospective single-arm study (STEP-Ca study) - STEP-Ca study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061260030

Enrollment

Registered

2026-06-16

Start date

2026-06-26

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Peripheral blood stem cell donors PBSC collection, Apheresis, Healthy donor, Citrate reaction, Calcium supplementation

Interventions

To prevent citrate-related reactions during peripheral blood stem cell (PBSC) collection, calcium supplementation will be administered both orally and intravenously. Intravenous calcium infusion will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Peripheral blood stem cell (PBSC) donors 2. Age >=18 years at the time of informed consent 3. Individuals who have received adequate explanation of the study and have provided written informed consent voluntarily

Exclusion criteria

Exclusion criteria: 1. Body weight <45 kg 2. Total blood volume (TBV) <3 L 3. Any donor considered inappropriate for participation in the study by the principal investigator or sub-investigators

Design outcomes

Primary

Measure	Time frame
1. Safety: Incidence of severe citrate reactions (Grade 3 to 4) during peripheral blood stem cell collection. 2. Feasibility: Proportion of procedures successfully completed under prophylactic intravenous calcium infusion at 10 mL/h.	—

Secondary

Measure	Time frame
1. Incidence of citrate reactions of Grade 1 to 2. 2. Effectiveness of oral intervention: proportion of cases in which Grade 1 symptoms improved to Grade 0, and proportion of cases remaining at Grade 1. 3. Frequency of intravenous rescue calcium administration, including the number and timing of administrations during the procedure. 4. Exploratory evaluation of changes in electrolyte levels (including ionized calcium [iCa] and ionized potassium [iK]) at the start and end of apheresis and at the time of symptom onset.	—

Measure

Time frame

1. Incidence of citrate reactions of Grade 1 to 2. 2. Effectiveness of oral intervention: proportion of cases in which Grade 1 symptoms improved to Grade 0, and proportion of cases remaining at Grade 1. 3. Frequency of intravenous rescue calcium administration, including the number and timing of administrations during the procedure. 4. Exploratory evaluation of changes in electrolyte levels (including ionized calcium [iCa] and ionized potassium [iK]) at the start and end of apheresis and at the time of symptom onset.

—

Contacts

Public ContactKeiko Fujii

Okayama University Hospital

pwxc0mv9@s.okayama-u.ac.jp+81-86-235-7227

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026