Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

Not Applicable

• Conditions: Thrombophilia; Migraine
• Interventions: Other: Laboratory tests

• Registration Number: NCT01905748
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-09-27
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-10-31
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients during Migraine attacks	Laboratory tests	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.
Control group	Laboratory tests	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients with activation of the coagulation system.	Two years, each patient will be studied at attack onset and after 72 hours.	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.

Trial Locations

Locations (1)

Ha'Emek Medical Center; 🇮🇱 Afula, Israel