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

D-dimer and the Use of Anticoagulation in IIH

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Intracranial Hypertension
• Intervention / Treatment: Drug: LMWH; Drug: acetazolamide

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt, 63611
    • Fayoum University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum quantitative D-dimer	higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls	Baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Frisen classification for papilledema	papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Visual acuity (Log Mar)	Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Visual field (Perimetry)	Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months
Visual Evoked Potentials (VEP)	VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)	6 months

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2017
• Primary Completion (Actual): July 23, 2018
• Study Completion (Actual): August 2, 2018

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 22, 2019
• First Posted (Actual): May 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: anticoagulation; D-dimer; IIH; microthrombi
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: M201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No