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

Early Phase 1CompletedNCT03963336

Fayoum University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Idiopathic Intracranial Hypertension

Interventions

LMWHDRUG

Subcutaneous LMWH 1mg/kg/day for 2 weeks

acetazolamideDRUG

Carbonic anhydrase inhibitor 1-2g/day for 6 months

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fayoum University Hospital

Al Fayyum, Egypt

Outcomes

Primary Outcomes

serum quantitative D-dimer

higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls

Time frame: Baseline assessment

Secondary Outcomes

HIT6 score

The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Time frame: 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)

Time frame: 6 months

Visual acuity (Log Mar)

Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Time frame: 6 months

Visual field (Perimetry)

Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Time frame: 6 months

Visual Evoked Potentials (VEP)

VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Time frame: 6 months

Data from ClinicalTrials.gov

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