ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair.
Reason given: Futility
Key facts
- Phase
- Phase 4
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
Trial details
- Who runs it
- Dijklander Ziekenhuis
- Trial code
- NCT04061798
- Record updated
- 6 February 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.