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

Early Phase 1

Completed

• Conditions: Idiopathic Intracranial Hypertension
• Interventions: Drug: LMWH; Drug: acetazolamide

• Registration Number: NCT03963336
• Lead Sponsor: Fayoum University

Brief 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.

Study Timeline

• Study Start: 2017-07-22
• Primary Completion: 2018-07-23
• Study Completion: 2018-08-02
• Status Verified: 2019-05
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-24
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	LMWH	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 A	acetazolamide	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	acetazolamide	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)

Primary Outcome Measures

Name	Time	Method
serum quantitative D-dimer	Baseline assessment	higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls

Secondary Outcome Measures

Name	Time	Method
HIT6 score	1 and 6 months	The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual acuity (Log Mar)	6 months	Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual field (Perimetry)	6 months	Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual Evoked Potentials (VEP)	6 months	VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Frisen classification for papilledema	6 months	papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Trial Locations

Locations (1)

Fayoum University Hospital; 🇪🇬 Fayoum, Egypt