Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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D-dimer and the Use of Anticoagulation in IIH

Conditions
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Idiopathic Intracranial Hypertension

Intervention / Treatment
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* Drug: LMWH
* Drug: acetazolamide


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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) | Drug: LMWH<br>* Subcutaneous LMWH 1mg/kg/day for 2 weeks<br>* Other names: Clexan;Drug: acetazolamide<br>* Carbonic anhydrase inhibitor 1-2g/day for 6 months<br>* Other names: Diamox;|
| Active Comparator: Group B<br>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) | Drug: acetazolamide<br>* Carbonic anhydrase inhibitor 1-2g/day for 6 months<br>* Other names: Diamox;|
| No Intervention: Control group<br>24 healthy subjects for whom serum D-dimer was assessed by ELISA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IIH, D-dimer, microthrombi, anticoagulation