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

• ClinicalTrials.gov Identifier: NCT03963336
• Recruitment Status: Completed
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Sponsor: Fayoum University
• Information provided by (Responsible Party): Sherine El Mously, Fayoum University

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 (Clinical Trial)
• 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: July 22, 2017
• Actual Primary Completion Date: July 23, 2018
• Actual Study Completion Date: August 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 Name: Clexan; Drug: acetazolamide; Carbonic anhydrase inhibitor 1-2g/day for 6 months; Other Name: 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 Name: Diamox
No Intervention: Control group; 24 healthy subjects for whom serum D-dimer was assessed by ELISA.

Outcome Measures

Primary Outcome Measures :

1. serum quantitative D-dimer [ Time Frame: Baseline assessment ]
   higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls

Secondary Outcome Measures :

1. HIT6 score [ Time Frame: 1 and 6 months ]
   The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
2. Frisen classification for papilledema [ Time Frame: 6 months ]
   papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
3. Visual acuity (Log Mar) [ Time Frame: 6 months ]
   Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
4. Visual field (Perimetry) [ Time Frame: 6 months ]
   Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
5. Visual Evoked Potentials (VEP) [ Time Frame: 6 months ]
   VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Fayoum University Hospital

Fayoum, Egypt, 63611

Sponsors and Collaborators

Fayoum University

More Information

• Responsible Party: Sherine El Mously, Assistant Professor, Fayoum University
• ClinicalTrials.gov Identifier: NCT03963336
• Other Study ID Numbers: M201
• First Posted: May 24, 2019
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Sherine El Mously, Fayoum University:

IIH; D-dimer; microthrombi; anticoagulation

Additional relevant MeSH terms:

Intracranial Hypertension; Pseudotumor Cerebri; Hypertension; Vascular Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Acetazolamide; Anticonvulsants; Carbonic Anhydrase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Diuretics; Natriuretic Agents; Physiological Effects of Drugs