ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial. - ACTION-1

Dijklander Ziekenhuis, lawfully represented by mw. Y.S. Fokma, MSc, member board of directors0 个研究点目标入组 750 人开始时间: 2020年1月21日最近更新: 2021年4月5日

适应症

试验速览

暂无简介。

•- Able to speak and read in local language of trial hospital.
•- Patients older than 18 years scheduled for elective, open repair of an iliac or abdominal aortic aneurysm distal of the SMA (DSAA segment C).
•- Implantation of a tube or bifurcation prosthesis.
•- Trans-abdominal or retroperitoneal surgical approach of aneurysm.
•- Able and willing to provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 650

•- Not able to provide written informed consent.
•- Previous open or endovascular intervention on the abdominal aorta (previous surgery on other parts of the aorta or iliac arteries is not an exclusion criterion).
•- History of coagulation disorders, heparin induced thrombocytopenia (HIT), allergy for heparin or thrombocyte pathology.
•- Impaired renal function with EGFR below 30 ml/min.
•- Acute open AAA surgery.
•- Hybrid interventions.
•- Connective tissue disorders.
•- Dual anti-platelet therapy, which cannot be discontinued.
•- Life expectancy less than 2 years.
•- Inflammatory, mycotic or infected aneurysms.
•- Allergy for fish protein or protamine

发起方

Dijklander Ziekenhuis, lawfully represented by mw. Y.S. Fokma, MSc, member board of directors