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

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
LMWH
acetazolamide
Sponsored by
Fayoum University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring IIH, D-dimer, microthrombi, anticoagulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Fayoum University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Group A

Group B

Control group

Arm Description

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)

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HIT6 score
The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Frisen classification for papilledema
papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual acuity (Log Mar)
Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual field (Perimetry)
Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Visual Evoked Potentials (VEP)
VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)

Full Information

First Posted
May 15, 2019
Last Updated
May 22, 2019
Sponsor
Fayoum University
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1. Study Identification

Unique Protocol Identification Number
NCT03963336
Brief Title
Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension
Official Title
D-dimer and the Use of Anticoagulation in IIH
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 22, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
August 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
IIH, D-dimer, microthrombi, anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
24 healthy subjects for whom serum D-dimer was assessed by ELISA.
Intervention Type
Drug
Intervention Name(s)
LMWH
Other Intervention Name(s)
Clexan
Intervention Description
Subcutaneous LMWH 1mg/kg/day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Carbonic anhydrase inhibitor 1-2g/day for 6 months
Primary Outcome Measure Information:
Title
serum quantitative D-dimer
Description
higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls
Time Frame
Baseline assessment
Secondary Outcome Measure Information:
Title
HIT6 score
Description
The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time Frame
1 and 6 months
Title
Frisen classification for papilledema
Description
papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time Frame
6 months
Title
Visual acuity (Log Mar)
Description
Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time Frame
6 months
Title
Visual field (Perimetry)
Description
Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time Frame
6 months
Title
Visual Evoked Potentials (VEP)
Description
VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Fayoum University Hospital
City
Fayoum
ZIP/Postal Code
63611
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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