ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.
Megadott ok: Futility
A legfontosabb adatok
- Fázis
- 4. fázis
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Dijklander Ziekenhuis
- Azonosító
- NCT04061798
- A regiszteradat frissítve
- 2025. február 6.
- Eredeti leírás
Aim of the ACTION-1 study is to determine whether ACT guided heparinization decreases thrombo-embolic complications (TEC) and mortality after elective open AAA surgery, without causing more bleeding complications.A teljes eredeti leírásKevesebb
ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial.
Aim of the ACTION-1 study is to determine whether ACT guided heparinization decreases thrombo-embolic complications (TEC) and mortality after elective open AAA surgery, without causing more bleeding complications.
Bevonási feltételek: 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 Superior Mesenteric Artery (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.
Kizáró feltételek: 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); Acute open AAA surgery; History of coagulation disorders, heparin induced thrombocytopenia (HIT), allergy for heparin or thrombocyte pathology; Connective tissue disorders; Inflammatory, mycotic or infected aneurysms; Allergy for protamine or fish protein; Impaired renal function with EGFR below 30 ml/min; Dual anti-platelet therapy, which cannot be discontinued; Not able to provide written informed consent; Hybrid interventions; Life expectancy less than 2 years.