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

NCT ID: NCT03963336

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-22
• Study Completion Date: 2018-08-02

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.

Conditions

Idiopathic Intracranial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

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 Type: ACTIVE_COMPARATOR

LMWH

Intervention Type: DRUG

Subcutaneous LMWH 1mg/kg/day for 2 weeks

acetazolamide

Intervention Type: DRUG

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

Group B

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)

Group Type: ACTIVE_COMPARATOR

acetazolamide

Intervention Type: DRUG

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

Control group

24 healthy subjects for whom serum D-dimer was assessed by ELISA.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LMWH

Subcutaneous LMWH 1mg/kg/day for 2 weeks

Intervention Type: DRUG

acetazolamide

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

Intervention Type: DRUG

Other Intervention Names

Clexan; Diamox

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Sherine El Mously

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fayoum University Hospital

Al Fayyum, , Egypt

Countries

Egypt

Other Identifiers

M201

Identifier Type: -

Identifier Source: org_study_id