Fayoum University Hospital
Al Fayyum, 63611, Egypt
NCT Number: NCT03963336
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.
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Interventional
Early Phase 1
Al Fayyum, 63611, Egypt
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous LMWH 1mg/kg/day for 2 weeks
Other names: Clexan
Carbonic anhydrase inhibitor 1-2g/day for 6 months
Other names: Diamox
Time frame: Baseline assessment
higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls
Time frame: 1 and 6 months
The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time frame: 6 months
papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time frame: 6 months
Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time frame: 6 months
Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time frame: 6 months
VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Fayoum University
Other
D-dimer and the Use of Anticoagulation in IIH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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