NL-OMON55676已完成4 期
ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial. - ACTION-1
Dijklander Ziekenhuis0 个研究点目标入组 279 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 279
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64(—)
入选标准
- •- 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.
排除标准
- •- Not able to provide written informed consent.
- •- Previous (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
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