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

NCT03963336 | Completed Early Phase 1 DMC

• 1 other identifier: M201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension

Keywords

IIH; D-dimer; microthrombi; anticoagulation

Outcome Measures

Primary Outcomes (1)

• serum quantitative D-dimer

  higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls

  Baseline assessment

Secondary Outcomes (5)

• HIT6 score

  1 and 6 months

• Frisen classification for papilledema

  6 months

• Visual acuity (Log Mar)

  6 months

• Visual field (Perimetry)

  6 months

• Visual Evoked Potentials (VEP)

  6 months

Study Arms (3)

Group A

ACTIVE COMPARATOR

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; Drug: acetazolamide

Group B

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

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

Interventions

LMWH DRUG

Subcutaneous LMWH 1mg/kg/day for 2 weeks

Also known as: Clexan

Group A

acetazolamide DRUG

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

Also known as: Diamox

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IIH patients of both sexes fulfilling the modified Dandy criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, 63611, Egypt

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Heparin, Low-Molecular-Weight; Acetazolamide

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 24, 2019
• Study Start: July 22, 2017
• Primary Completion: July 23, 2018
• Study Completion: August 2, 2018
• Last Updated: May 24, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)