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

Epilepsy in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675254
• Other study ID #: No. 2022-355
• Status: Completed
• Start date: December 1, 2022
• Est. completion date: December 24, 2022

Study information

• Verified date: December 2022
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Epilepsy is a common disease of the nervous system with severe consequences. Epidemiological surveys have shown that the prevalence of epilepsy in China is approximately 0.4-0.7%, comprising 7-10 million patients with epilepsy, most of whom are children. Although most symptoms of epilepsy can be controlled with the use of anti-seizure medications (ASMs), there are still a few patients who cannot achieve satisfactory seizure control with such medications or cannot tolerate their side effects, thus requiring surgical treatment. Surgical treatment of epilepsy has been recognized as a valuable treatment option for carefully selected patients to achieve better seizure control and quality of life. Compared to adults, children with epilepsy with indications for surgery usually have a better prognosis after surgical treatment. Many children undergoing surgery for epilepsy have a long history of using ASMs. Moreover, ASM therapy usually consists of multiple varieties of drugs, thereby bringing significant attention to the side effects of ASMs, especially those that may be relevant in the perioperative surgical setting.

ASMs have been associated with multiple adverse effects on platelets and the coagulation system. Valproic acid (VPA), one of the most commonly used traditional ASM, has been reported to cause multiple hematologic abnormalities, including thrombocytopenia, platelet aggregation dysfunction, fibrinogen (FBG) depletion, bone marrow suppression, decreased factor XIII, and acquired von Willebrand disease. However, the wide use of novel ASMs in recent decades has led to decreased reports of adverse events. The hematologic consequences of these novel ASMs or combined therapies are rarely reported. Few studies have suggested that levetiracetam (LEV) does not cause clinically significant or relevant hematological disorders.

Such reported side effects may be more significant in pediatric patients with epilepsy due to individual differences in age, weight, and pharmacokinetic action of the body on the drugs. The incidence of coagulopathies has been reported to be higher in children than in adults, especially hypofibrinogenemia. Nevertheless, whether these coagulation dysfunctions increase the risk of peri-operative bleeding remains controversial. Most investigators suggest that ASMs, including VPA, are not associated with surgery-related blood loss or transfusion requirements. However, a few studies have suggested that considering the extra risk of peri-operative bleeding, VPA should be discontinued before surgery.

This retrospective analysis of 390 children with epilepsy systematically investigated the incidence and risk factors of preoperative coagulation dysfunction in children undergoing surgery for epilepsy and their impact on surgery, with the objective to provide detailed and valuable clinical information.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: December 24, 2022
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• The clinical information or laboratory examinations were incomplete

• Had concomitant diseases affecting coagulation or liver function

• Patients or parents refused to be enrolled

Related Conditions & MeSH terms

• Coagulation and Hemorrhagic Disorders
• Epilepsy
• Epilepsy in Children
• Epilepsy; Seizure
• Hemorrhagic Disorders
• Seizures

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of coagulation dysfunction between groups	Proportion of cases with or without coagulation dysfunction in epileptic children with ASMs, epileptic children without ASMs, and non-epileptic children.	From hospitalization to surgery, an average of 3 days
Secondary	Variables affecting coagulation function	Univariate analysis and logistic regression identified the risk factors for coagulopathy in paediatric patients undergoing epilepsy surgery.	From hospitalization to surgery, an average of 3 days
Secondary	Affected laboratory index	Laboratory index affected by the independent determinants of coagulation dysfunction (PT, APTT, FBG or PLT).	From hospitalization to surgery, an average of 3 days
Secondary	Incidence of transfusion	Whether the independent determinants of coagulation dysfunction increase the incidence of surgical-related transfusion.	From surgery to discharge, an average of 7 days