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Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905748
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2013
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE September 27, 2011
First Posted Date  ICMJE July 23, 2013
Last Update Posted Date October 31, 2019
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
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. ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine
Official Title  ICMJE Acute Phase Reactions and Thrombophilia in Pediatric Patients With Migraine, Laboratory Investigations in Steady State and During Migraine Attack
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Migraine
  • Thrombophilia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Laboratory tests
  • 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
    Intervention: Other: Laboratory tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01905748
Other Study ID Numbers  ICMJE 0040-09-EMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Koren Ariel, HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ariel Koren, MD Ha'Emek Medical Center, Afula, Israel
PRS Account HaEmek Medical Center, Israel
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP