D-dimer and the Use of Anticoagulation in IIH
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- serum quantitative D-dimer
研究概览
简要总结
Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology.
The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.
详细描述
24 patients with IIH according to the modified Dandy criteria were enrolled. Headache impact test (HIT6), ophthalmological assessment including Frisen classification for papilledema, visual acuity, visual field by perimetry, and visual evoked potentials were performed to the patients.
Serum quantitative D-dimer level was measured using the enzyme-linked immunosorbent assay (ELISA) technique for the patients and for 24 healthy matched controls.
Patients were divided into two groups: group (A) received acetazolamide and low molecular weight heparin (LMWH) in a prophylactic dose for 2 weeks while group (B) received acetazolamide only. Both groups continued the acetazolamide 1-2g/day for 6 months.
The investigators followed-up the patients after one and six months later through the HIT6 test and the ophthalmological assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IIH patients of both sexes fulfilling the modified Dandy criteria
排除标准
- •disturbed conscious level, focal neurological signs, seizures, cerebral venous sinus thrombosis or stenosis, deep venous thrombosis or pulmonary embolism, malignancy, and acute nephritic syndrome.
- •Patients with signs of disseminated intravascular coagulopathy and septic sinus thrombosis
- •patients with a history of cerebral granuloma or infection, cerebrovascular stroke, head trauma or surgery.
- •pregnant females or those who terminated their pregnancy in the last four weeks were also excluded.
研究组 & 干预措施
Group A
12 IIH patients for whom serum D-dimer was assessed by ELISA.They received acetazolamide and anticoagulant LMWH in the prophylactic dose for 2 weeks then continued on acetazolamide. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials)
干预措施: LMWH (Drug)
Group A
12 IIH patients for whom serum D-dimer was assessed by ELISA.They received acetazolamide and anticoagulant LMWH in the prophylactic dose for 2 weeks then continued on acetazolamide. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials)
干预措施: acetazolamide (Drug)
Group B
12 IIH patients for whom serum D-dimer was assessed by ELISA. They received acetazolamide only. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials)
干预措施: acetazolamide (Drug)
结局指标
主要结局
serum quantitative D-dimer
时间窗: Baseline assessment
higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls
次要结局
- HIT6 score(1 and 6 months)
- Visual acuity (Log Mar)(6 months)
- Visual field (Perimetry)(6 months)
- Visual Evoked Potentials (VEP)(6 months)
- Frisen classification for papilledema(6 months)
研究者
Sherine El Mously
Assistant Professor
Fayoum University