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

Sponsor

Fayoum University (Other)

Overall Status

Completed

CT.gov ID

NCT03963336

Collaborator

(none)

Enrollment

Location

Arms

12.4

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Intracranial Hypertension	Drug: LMWH Drug: acetazolamide	Early Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

D-dimer and the Use of Anticoagulation in IIH

Actual Study Start Date :

Jul 22, 2017

Actual Primary Completion Date :

Jul 23, 2018

Actual Study Completion Date :

Aug 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)	Drug: LMWH Subcutaneous LMWH 1mg/kg/day for 2 weeks Other Names: Clexan Drug: acetazolamide Carbonic anhydrase inhibitor 1-2g/day for 6 months Other Names: Diamox
Active Comparator: 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)	Drug: acetazolamide Carbonic anhydrase inhibitor 1-2g/day for 6 months Other Names: Diamox
No Intervention: Control group 24 healthy subjects for whom serum D-dimer was assessed by ELISA.

Arm

Intervention/Treatment

Active Comparator: 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)

Drug: LMWH

Subcutaneous LMWH 1mg/kg/day for 2 weeks

Other Names:

Clexan

Drug: acetazolamide

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

Other Names:

Diamox

Active Comparator: 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)

Drug: acetazolamide

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

Other Names:

Diamox

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

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

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)
Frisen classification for papilledema [6 months]
papilledema 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.