臨床研究等提出・公開システム

Date of registration	Oct. 31, 2023
Last modified on	Oct. 31, 2023
Trial ID	jRCT1022230028

Scientific Title	Blood drawing methods for Preservation of Platelet Function in ANH: a pilot study
Public Title	Blood drawing methods for Preservation of Platelet Function in ANH: a pilot study

Contact for Scientific Queries	Name	Ichikawa Shino
	Affiliation	Hirosaki University Hospital
	Address	53, Honcho, Hirosaki, Aomori
	Telephone	+81-8060163377
	E-mail	shinooooo.119@hotmail.co.jp
Contact for Public Queries	Name	Ichikawa Shino
	Affiliation	Hirosaki University Hospital
	Address	53, Honcho, Hirosaki, Aomori
	Telephone	+81-8060163377
	E-mail	shinooooo.119@hotmail.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 31, 2023
Target sample size		10
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Adults gynecological surgery patients in Hirosaki University Hospital. Each arm has 5 patients.
	Exclusion Criteria	1)Patients who had antiplatelet drugs or anticoagulant 2 weeks before surgery 2)Patients who were suspected coagulopathy or abnormality of platelet function 3)Patients who do not have informed consents in Japanese
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		gynecological cancer
Intervention(s)		Arterial blood arm: Patients are mechanically ventilated at the fraction of inspired oxygen (FIO2) 1.0 and end-tidal CO2 concentrations of 40mm Hg during a blood draw. Venous blood arm: Patients are mechanically ventilated at the fraction of inspired oxygen (FIO2) 0.4 and end-tidal CO2 concentrations of 40mm Hg during a blood draw.
Primary Outcome(s)		Measurement items by thromboelastogram (TEG6s system) in ANH blood
Secondary Outcome(s)		1)Characteristics of the patient: age, height, body weight 2)ASA physical status before surgery, past medical history, medicine taken internally 3)Operative time, anesthesia time, time to retransfusion from drawing blood 4)Amount of bleeding during surgery, infusion volume, amount of blood transfusion 5)The temperature during storage at room air 6)Vital signs in the perioperative period 7)Blood biochemical paramaters in th perioperative period

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Hirosaki University General Certified Review Board
Address	1, Bunkyo, Hirosaki, Aomori
Telephone	+81-172-39-5362
E-Mail	crb-hirosaki@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	May. 24, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none