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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Idiopathic Intracranial Hypertension | Drug: LMWH Drug: acetazolamide | Early Phase 1 |
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 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 |
| 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.
|
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
| Egypt | |
| Fayoum University Hospital | |
| Fayoum, Egypt, 63611 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 15, 2019 | ||||||
| First Posted Date ICMJE | May 24, 2019 | ||||||
| Last Update Posted Date | May 24, 2019 | ||||||
| Actual Study Start Date ICMJE | July 22, 2017 | ||||||
| Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension | ||||||
| Official Title ICMJE | D-dimer and the Use of Anticoagulation in IIH | ||||||
| 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. |
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| 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 ICMJE | Interventional | ||||||
| Study Phase ICMJE | Early Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Idiopathic Intracranial Hypertension | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
48 | ||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | August 2, 2018 | ||||||
| Actual Primary Completion Date | July 23, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Egypt | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03963336 | ||||||
| Other Study ID Numbers ICMJE | M201 | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Sherine El Mously, Fayoum University | ||||||
| Study Sponsor ICMJE | Fayoum University | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Fayoum University | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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