Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by HaEmek Medical Center, Israel
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01905748
First received: September 27, 2011
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention
Migraine
Thrombophilia
Other: Laboratory tests

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Proportion of patients with activation of the coagulation system. [ Time Frame: Two years, each patient will be studied at attack onset and after 72 hours. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 15
Study Start Date: August 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905748

Contacts
Contact: Ariel Koren, MD 972-4-6495576 ext 5576 koren_a@clalit.org.il

Locations
Israel
Ha'Emek Medical Center Recruiting
Afula, Israel, 18101
Contact: Arial Koren, MD    972-4-6495576    koren_a@clalit.org.il   
Principal Investigator: Ariel Koren, MD         
Sub-Investigator: Carina Levin, MD         
Sub-Investigator: Miriam Kutay, MD         
Sub-Investigator: Stavit Shalev, MD         
Sub-Investigator: Luci Zalman, PhD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Ariel Koren, MD Ha'Emek Medical Center, Afula, Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01905748     History of Changes
Other Study ID Numbers: 0040-09-EMC
Study First Received: September 27, 2011
Last Updated: July 18, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Coagulation

Additional relevant MeSH terms:
Thrombophilia
Acute-Phase Reaction
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Hematologic Diseases
Inflammation
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014