Deferoxamine in Aneurysmal Subarachnoid Hemorrhage pilot trial - DASH trial

Radboudumc0 个研究点目标入组 20 人开始时间: 2018年2月19日最近更新: 2020年6月15日

适应症

试验速览

暂无简介。

•18-85 years old inclusive,
•Subarachnoid hemorrhage diagnosed by CT on admission,
•No history of possible traumatic origin of subarachnoid hemorrhage,
•Randomizable within 72 hours of subarachnoid hemorrhage,
•Saccular intracranial aneurysm proven by cerebral angiography or CTA,
•Surgical or endovascular obliteration is successfully performed,
•Able to obtain written informed consent from patient or surrogate.
•Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Pregnancy, as confirmed by routine urine test on admission,
•Abnormal renal function at time of randomization (GFR <60 mL/min)
•Elevated liver function test at time of randomization (AST > 45 U/L and ALT > 35 U/L.)
•History of liver disease or active liver disease, Active renal disease,
•Patients with low ferritine (<1000 ng/mL)
•Hypersensitivity to deferoxamine,
•Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication).
•Patients not able to complete the study follow-up.
•The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:tachypnea (respiratory rate>30), SpO2<95%, Obesity (BMI>30) Acidosis (pH<7.35), Hypoalbuminemia (albumin<3.5g/dL), Concurrent use of chemotherapy
•-Tachypnea (respiratory rate >30),
•-SpO2 <95%,
•-Obesity (BMI >30)
•-Acidosis (pH <7.35),
•-Hypoalbuminemia (albumin <3.5 g/dL),
•-Concurrent use of chemotherapy

发起方