Back to resultsAcute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine
Primary Purpose
Migraine, Thrombophilia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Laboratory tests
Sponsored by
About this trial
This is an interventional diagnostic trial for Migraine focused on measuring Coagulation
Eligibility Criteria
Inclusion Criteria:
- Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.
Exclusion Criteria:
- Patients with other underlying neurological conditions of coagulation diseases
Sites / Locations
- Ha'Emek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients during Migraine attacks
Control group
Arm Description
Patients with Migraine before, during and after Migraine attacks. Acute phase reaction profile, and activation of the coagulation system will be investigated together with thrombophilia profile.
Patients with acute neurologic events like convulsions not related to fever or central nervous system (CNS) infections will be studied including acute phase reaction laboratory tests, thrombophilia and activation of the coagulation system
Outcomes
Primary Outcome Measures
Proportion of patients with activation of the coagulation system.
The further analysis will be performed in each patient: Pt, PTT, Platelets, Protein C, S, Antithrombin III, D Dimer, Factor VIII, Factor IX, Von Willebrand Factor and Prothrombin fragments I and II will be analyzed on day one of the crises, after 72 hours and in steady state.
Secondary Outcome Measures
Full Information
NCT ID
NCT01905748
First Posted
September 27, 2011
Last Updated
October 30, 2019
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT01905748
Brief Title
Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine
Official Title
Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine, Laboratory Investigations in Steady State and During Migraine Attack
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Acute Migraine attacks can be related to vascular or coagulation activation. Previous studies found relative high incidence of prothrombotic events in Migraine. The present study intends to assess the coagulation system and activation in patients with Migraine during steady state phase and at the beginning of attacks and after 72 hours. A control group of patients with another acute neurologic event like convulsions will be also studied. Patients will be at pediatric age and teenagers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Thrombophilia
Keywords
Coagulation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients during Migraine attacks
Arm Type
Experimental
Arm Description
Patients with Migraine before, during and after Migraine attacks. Acute phase reaction profile, and activation of the coagulation system will be investigated together with thrombophilia profile.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Patients with acute neurologic events like convulsions not related to fever or central nervous system (CNS) infections will be studied including acute phase reaction laboratory tests, thrombophilia and activation of the coagulation system
Intervention Type
Other
Intervention Name(s)
Laboratory tests
Intervention Description
Laboratory tests: erythrocyte sedimentation rate (ESR), Blood Count, C reactive Protein, Protein C activity, Protein S activity,Antithrombin II activity, Coagulation Factor VIII and IX,Con Willebrand Factor, prothrombin time (PT), activated partial thromboplastin time (aPTT), Fibrinogen, D Dimer and Prothrombin Fragments F1 and F2.
Primary Outcome Measure Information:
Title
Proportion of patients with activation of the coagulation system.
Description
The further analysis will be performed in each patient: Pt, PTT, Platelets, Protein C, S, Antithrombin III, D Dimer, Factor VIII, Factor IX, Von Willebrand Factor and Prothrombin fragments I and II will be analyzed on day one of the crises, after 72 hours and in steady state.
Time Frame
Two years, each patient will be studied at attack onset and after 72 hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.
Exclusion Criteria:
Patients with other underlying neurological conditions of coagulation diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Koren, MD
Organizational Affiliation
Ha'Emek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine
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