Idiopathic Intracranial Hypertension
Conditions
Keywords
IIH, D-dimer, microthrombi, anticoagulation
Brief summary
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.
Detailed description
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.
Interventions
DRUGLMWH
Subcutaneous LMWH 1mg/kg/day for 2 weeks
DRUGacetazolamide
Carbonic anhydrase inhibitor 1-2g/day for 6 months
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* IIH patients of both sexes fulfilling the modified Dandy criteria
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum quantitative D-dimer | Baseline assessment | higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIT6 score | 1 and 6 months | The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
| Frisen classification for papilledema | 6 months | papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
| Visual acuity (Log Mar) | 6 months | Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
| Visual field (Perimetry) | 6 months | Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
| Visual Evoked Potentials (VEP) | 6 months | VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
Countries
Egypt
Outcome results
None listed