NCT03963336

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

D-dimer and the Use of Anticoagulation in IIH

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Fayoum University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Idiopathic Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	LMWH	Subcutaneous LMWH 1mg/kg/day for 2 weeks
DRUG	acetazolamide	Carbonic anhydrase inhibitor 1-2g/day for 6 months

Timeline

• Start date: 2017-07-22
• Primary completion: 2018-07-23
• Completion: 2018-08-02
• First posted: 2019-05-24
• Last updated: 2019-05-24

Locations

1 site across 1 country: Egypt