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

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

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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.



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)



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963336


Locations
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Egypt
Fayoum University Hospital
Fayoum, Egypt, 63611
Sponsors and Collaborators
Fayoum University

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Responsible Party: Sherine El Mously, Assistant Professor, Fayoum University
ClinicalTrials.gov Identifier: NCT03963336     History of Changes
Other Study ID Numbers: M201
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Intracranial Hypertension
Pseudotumor Cerebri
Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Acetazolamide
Fibrin fragment D
Anticoagulants
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants