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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 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) |
|
| Group B | Active Comparator | 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) |
|
| Control group | No Intervention | 24 healthy subjects for whom serum D-dimer was assessed by ELISA. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMWH | Drug | Subcutaneous LMWH 1mg/kg/day for 2 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| serum quantitative D-dimer | higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls | Baseline assessment |
| Measure | Description | Time Frame |
|---|---|---|
| HIT6 score | The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) | 1 and 6 months |
| Frisen classification for papilledema | papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University Hospital | Al Fayyum | 63611 | Egypt |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| acetazolamide | Drug | Carbonic anhydrase inhibitor 1-2g/day for 6 months |
|
|
| 6 months |
| Visual acuity (Log Mar) | Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) | 6 months |
| Visual field (Perimetry) | Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) | 6 months |
| Visual Evoked Potentials (VEP) | VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH) | 6 months |
| D013830 |
| Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |