Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01905748
• Other study ID #: 0040-09-EMC
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 15
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Migraine
• Migraine Disorders
• Thrombophilia

Intervention

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.

Locations

Country	Name	City	State
Israel	Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.