臨床研究等提出・公開システム

Scientific Title	High concentrated sodium citrate versus ACD-A for leukapheresis without heparin using centrifugal separation : Open-label, randomized, controlled trial
Public Title	ACD-HC trial

Contact for Scientific Queries	Name	Fujii Keiko
	Affiliation	Okayama University Hospital
	Address	2-5-1, Shikata-cho, Kita-ku, Okayama
	Telephone	+81-86-235-7768
	E-mail	keikofujii@s.okayama-u.ac.jp
Contact for Public Queries	Name	Fujii Keiko
	Affiliation	Okayama University Hospital
	Address	2-5-1, Shikata-chi, Kita-ku, Okayama
	Telephone	+81-86-235-7768
	E-mail	keikofujii@s.okayama-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		May. 15, 2025
Actual date of first enrollment		May. 23, 2025
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	PBSC donor Persons 16 years old and older TBV 4.5 liter or less
	Exclusion Criteria	Peripheral blood stem cell donors registered with the Japan Marrow Donor Program Persons who are recommended custom priming because whose TBV and Hct values are low
	Age Minimum	16age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		PBSC donor
Intervention(s)		Peripheral blood stem cell collection using 5.3% sodium citrate solution (ACD-HC)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		procedure time due to apheresis
Secondary Outcome(s)		total amount of AC product quality assesement collection efficiency platelet reduction rate incidence of adverse effect change in electrolyte values over time incidence rate of clumping and coagulating

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Okayama University Certified Review Bord
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Okayama
Telephone	+81-86-235-6503
E-Mail	ouh-crrb@adm.okayama-u.ac.jp
Approval Status	Approval
Date of approval	May. 02, 2025

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 03, 2025	(this page)	Changes
1	May. 15, 2025	Detail

List of change history