The Prevalence and Risk Factors of Coagulopathy in Pediatric Epilepsy Surgery Patients

NCT05675254 | Completed

• 1 other identifier: No. 2022-355
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

The hematologic consequences of novel Anti-seizure medications (ASMs) are rarely reported. Whether coagulation dysfunctions increase the risk of peri-operative bleeding remains controversial. The research is performed to investigated the incidence and risk factors of preoperative coagulation dysfunction in children undergoing surgery for epilepsy and their impact on surgery.

Conditions

Epilepsy in Children; Coagulation and Hemorrhagic Disorders; Epilepsy; Seizure; Antiepileptic Adverse Reaction

Keywords

Pediatric; Epilepsy; Surgery; Coagulation Function; Anti-seizure Medications

Outcome Measures

Primary Outcomes (1)

• Factors related to coagulation function

  The following clinical data were collected: sex, age, weight, epilepsy course, and anti-seizure therapy. The initial laboratory data after admission included platelet count (PLT), prothrombin time (PT), activated partial thromboplastin time (APTT), FBG, alanine aminotransferase (ALT), and aspartate aminotransferase (AST). We also collected data on non-epileptic children who underwent non-epilepsy neurological surgery and were admitted at the same period from the Hospital Information System (HIS) as a control cohort. Multivariate logistic regression analysis was performed to identify independent determinants of coagulation dysfunction. Possible relevant variables were filtered out using univariate logistic regression and further included as covariates for the multivariate logistic regression.

  From hospitalization to surgery, an average of 3 days

Secondary Outcomes (4)

• Proportion of coagulation dysfunction between groups

  From hospitalization to surgery, an average of 3 days

• Variables affecting coagulation function

  From hospitalization to surgery, an average of 3 days

• Affected laboratory index

  From hospitalization to surgery, an average of 3 days

• Incidence of transfusion

  From surgery to discharge, an average of 7 days

Study Arms (3)

EP with ASMs

Epilepsy patients who administered Anti-seizure Medications(ASMs)

EP without ASMs

Epilepsy patients who were not administered ASMs

No EP

Non-epileptic children and had never taken any ASMs

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population were children who were hospitalized between January 2015 and December 2021 at the Neurosurgery Department of Children's Hospital of Fudan University, including non-epileptic children who underwent non-epilepsy neurological surgery by the same surgeon and were admitted at the same period for control. * 319 patients with epilepsy who administered Anti-seizure Medications (ASMs); * 71 patients with epilepsy who were not administered ASMs; * 104 non-epileptic children who underwent neurosurgical operations and had never taken any ASMs.

You may qualify if:

• Age\<18 years
• A discharge diagnosis of "epilepsy" according to the International Classification of Diseases (ICD-10)
• Received surgical treatment for epilepsy during the hospitalization
• Hospitalized between January 2015 and December 2021 at the Neurosurgery Department of Children's Hospital of Fudan University
• Non-epileptic children who underwent non-epilepsy neurological surgery by the same surgeon and were admitted at the same period for control

You may not qualify if:

• The clinical information or laboratory examinations were incomplete
• Had concomitant diseases affecting coagulation or liver function
• Patients or parents refused to be enrolled

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• Zhu R, Wang Q, Zhou Y, Shi W, Zhang Y, Wang M, Li H, Zhao R. The prevalence and risk factors of coagulopathy in pediatric patients undergoing surgery for epilepsy. J Neurosurg Pediatr. 2023 Aug 18;32(5):527-534. doi: 10.3171/2023.6.PEDS23196. Print 2023 Nov 1.

  PMID: 37728406 DERIVED

MeSH Terms

Conditions

Thrombosis; Hemorrhagic Disorders; Epilepsy

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: December 1, 2022
• Primary Completion: December 24, 2022
• Study Completion: December 24, 2022
• Last Updated: January 9, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)