Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058307) titled 'A Study Comparing ACT Measurement Differences Between Cartridges in Cardiac Surgery with Cardiopulmonary Bypass' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Nagasaki University Hospital
Condition:
Condition - Cardiac diseases requiring cardiovascular surgery with cardiopulmonary bypass (regurgitant valvular disease, stenotic valvular disease, aortic aneurysm, ischemic heart disease)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aims to investigate the impact of differences between two types of ACT measurement cartridges (JACT-LR and JACT+) used with the Hemochron Signature Elite on ACT values during cardiac surgery with cardiopulmonary bypass.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Age: 18 years or older
Surgical procedure: Cardiovascular surgery using cardiopulmonary bypass (including valve replacement, valve repair, aortic replacement, and coronary artery bypass grafting)
Diseases: Cardiac diseases for which the above surgical procedures are indicated (such as regurgitant valvular disease, stenotic valvular disease, aortic aneurysm, and ischemic heart disease)
Timing of surgery to be included: From the date of approval by the institution's director to March 31, 2026
Consent: Patients who have provided written informed consent themselves or through a legally authorized representative
Key exclusion criteria - Patients with antiphospholipid syndrome
Patients currently participating in a clinical trial or specified clinical research
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2026 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066572
Disclaimer: Curated by HT Syndication.