Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Unknown status

CT.gov ID

NCT01905748

Collaborator

(none)

Enrollment

Location

Arms

113

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine Thrombophilia	Other: Laboratory tests	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine, Laboratory Investigations in Steady State and During Migraine Attack

Study Start Date :

Aug 1, 2011

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients during Migraine attacks 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 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.
Experimental: Control group 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 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.

Arm

Intervention/Treatment

Experimental: Patients during Migraine attacks

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

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.

Experimental: Control group

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ha'Emek Medical Center	Afula		Israel	18101

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator: Ariel Koren, MD, Ha'Emek Medical Center, Afula, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT01905748

Other Study ID Numbers:

0040-09-EMC

First Posted:

Jul 23, 2013

Last Update Posted:

Oct 31, 2019

Last Verified:

Oct 1, 2019

Keywords provided by Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel

Coagulation

Additional relevant MeSH terms:

Migraine Disorders

Thrombophilia

Acute-Phase Reaction

Study Results

No Results Posted as of Oct 31, 2019