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

NCT ID: NCT05675254

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 494 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2022-12-24

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

EP with ASMs

Epilepsy patients who administered Anti-seizure Medications(ASMs)

No interventions assigned to this group

EP without ASMs

Epilepsy patients who were not administered ASMs

No interventions assigned to this group

No EP

Non-epileptic children and had never taken any ASMs

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37728406 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

No. 2022-355

Identifier Type: -

Identifier Source: org_study_id