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

Idiopathic Intracranial Hypertension Clinical Trial

Official title:

D-dimer and the Use of Anticoagulation in IIH

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963336
• Other study ID #: M201
• Status: Completed
• Phase: Early Phase 1
• Start date: July 22, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: May 2019
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Drug:
• LMWH
Subcutaneous LMWH 1mg/kg/day for 2 weeks
• acetazolamide
Carbonic anhydrase inhibitor 1-2g/day for 6 months

Locations

Country	Name	City	State
Egypt	Fayoum University Hospital	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum quantitative D-dimer	higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls	Baseline assessment
Secondary	HIT6 score	The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	1 and 6 months
Secondary	Frisen classification for papilledema	papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Secondary	Visual acuity (Log Mar)	Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Secondary	Visual field (Perimetry)	Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Secondary	Visual Evoked Potentials (VEP)	VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months