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Completed

NCT Number: NCT03963336

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Fayoum University Hospital

Al Fayyum, 63611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LMWH

Drug

Subcutaneous LMWH 1mg/kg/day for 2 weeks

Other names: Clexan

Acetazolamide

Drug

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

Other names: Diamox

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

D-dimer and the Use of Anticoagulation in IIH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 24, 2019
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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