Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

NCT01905748 | Unknown DMC

• 1 other identifier: 0040-09-EMC
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Thrombophilia

Keywords

Coagulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years, each patient will be studied at attack onset and after 72 hours.

Study Arms (2)

Patients during Migraine attacks

EXPERIMENTAL

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.

Other: Laboratory tests

Control group

EXPERIMENTAL

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

Other: Laboratory tests

Interventions

Laboratory tests OTHER

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.

Control group; Patients during Migraine attacks

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients at the pediatric age (5 to 20 ys old) suffering from Migraine attacks diagnosed by a neurologist.

You may not qualify if:

• Patients with other underlying neurological conditions of coagulation diseases

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Ha'Emek Medical Center

Afula, 18101, Israel

Location

MeSH Terms

Conditions

Migraine Disorders; Thrombophilia; Thrombosis

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Ariel Koren, MD

  Ha'Emek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pediatric Dpt B and Pediatric Hematology Unit

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: July 23, 2013
• Study Start: August 1, 2011
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

IL (1)