Epilepsy in ChildrenNCT05675254
The Prevalence and Risk Factors of Coagulopathy in Pediatric Epilepsy Surgery Patients
An observational study of Epilepsy in Children and Coagulation and Hemorrhagic Disorders, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Epilepsy in Children, Coagulation and Hemorrhagic Disorders, Epilepsy; Seizure
- How many people
- 494 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 24 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- The clinical information or laboratory examinations were incomplete
- Had concomitant diseases affecting coagulation or liver function
- Patients or parents refused to be enrolled
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: The Prevalence and Risk Factors of Coagulopathy in Pediatric Patients Undergoing Surgery for Epilepsy
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.
Read the 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
- Keywords
- Pediatric, Epilepsy, Surgery, Coagulation Function, Anti-seizure Medications
- Medical subject headings
- Thrombosis, Hemorrhagic Disorders, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospitalization to surgery, an average of 3 days
Secondary outcomes (4)
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.
Measured: From hospitalization to surgery, an average of 3 days
Variables affecting coagulation function
Univariate analysis and logistic regression identified the risk factors for coagulopathy in paediatric patients undergoing epilepsy surgery.
Measured: From hospitalization to surgery, an average of 3 days
Affected laboratory index
Laboratory index affected by the independent determinants of coagulation dysfunction (PT, APTT, FBG or PLT).
Measured: From hospitalization to surgery, an average of 3 days
Incidence of transfusion
Whether the independent determinants of coagulation dysfunction increase the incidence of surgical-related transfusion.
Measured: From surgery to discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Dec 2022
- Primary completion24 Dec 2022
- Study completion24 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675254
- Sponsor's protocol ID
- No. 2022-355
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the Ethic Board of Children's Hospital of Fudan University, the clinical data of patients could not been shared without permission.
Publications
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.
PubMed 37728406
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Risk Factors of Coagulopathy in Pediatric Patients Undergoing Surgery for Epilepsy
- ClinicalTrials.gov ID
- NCT05675254
- Acronym / sponsor ID
- No. 2022-355
- Conditions
- Epilepsy in Children, Coagulation and Hemorrhagic Disorders, Epilepsy; Seizure, Antiepileptic Adverse Reaction
- Keywords
- Pediatric, Epilepsy, Surgery, Coagulation Function, Anti-seizure Medications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 24 Dec 2022 (actual)
- Study completion
- 24 Dec 2022 (actual)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- The clinical information or laboratory examinations were incomplete
- Had concomitant diseases affecting coagulation or liver function
- Patients or parents refused to be enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Factors related to coagulation function
Time frame: From hospitalization to surgery, an average of 3 days
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.
4 secondary outcomes
Proportion of coagulation dysfunction between groups
Time frame: From hospitalization to surgery, an average of 3 days
Variables affecting coagulation function
Time frame: From hospitalization to surgery, an average of 3 days
Affected laboratory index
Time frame: From hospitalization to surgery, an average of 3 days
Incidence of transfusion
Time frame: From surgery to discharge, an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 37728406Zhu 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.
- Individual participant dataSharing planned: No. According to the Ethic Board of Children's Hospital of Fudan University, the clinical data of patients could not been shared without permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy in Children and Coagulation and Hemorrhagic Disorders, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors related to coagulation function (time frame: From hospitalization to surgery, an average of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.