Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05846854
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-05-06
First Post:
2023-04-26
Brief Title:
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Novel Protocol to Decrease Peri-procedural and Intra-operative Hemorrhage in Children With Alagille Syndrome
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this interventional study is to test a hemostasis screening protocol and cardiac peri-procedural and post-operative hemostasis pathway to improving bleeding complications and improve patient survival for children with Alagille syndrome and complex cardiac conditions The main questions it aims to answer are
Are children with Alagille syndrome with cardiac anomalies more likely to have acquired von Willebrand syndrome a condition that causes increased bleeding
Does implementation of a novel screening protocol to detect pre-operative bleeding conditions decrease intra-operative andor post-operative bleeding complications and mortality risk
Does implementation of a novel screening protocol to detect and treat bleeding conditions cause thrombotic complications
Participants will undergo additional hematology and bleeding disorder screening prior to cardiac surgery They will additionally undergo a detailed family screening for a history of bleeding by a genetic counselor
Researchers will compare these findings with children who have similar complex cardiac conditions requiring surgery but who do not have Alagille syndrome to see if bleeding conditions and complications are more or less common in children with Alagille syndrome
Are children with Alagille syndrome with cardiac anomalies more likely to have acquired von Willebrand syndrome a condition that causes increased bleeding
Does implementation of a novel screening protocol to detect pre-operative bleeding conditions decrease intra-operative andor post-operative bleeding complications and mortality risk
Does implementation of a novel screening protocol to detect and treat bleeding conditions cause thrombotic complications
Participants will undergo additional hematology and bleeding disorder screening prior to cardiac surgery They will additionally undergo a detailed family screening for a history of bleeding by a genetic counselor
Researchers will compare these findings with children who have similar complex cardiac conditions requiring surgery but who do not have Alagille syndrome to see if bleeding conditions and complications are more or less common in children with Alagille syndrome
Detailed Description:
This study aims to develop and implement a pre-operative screening protocol prior to major procedures or surgeries for children with Alagille syndrome including cardiac catheterization and cardiothoracic surgery pulmonary artery reconstruction
Secondary Objectives
1 Develop and implement an intra-operative protocol for children with Alagille syndrome and acquired von willebrand syndrome
2 Compare cardiac intra- and up to 48 hour post-operative bleeding complications post-operative thrombotic complications within 30 days of surgery and mortality for a children with Alagille syndrome with and without acquired von willebrand syndrome and b children without Alagille syndrome
This is a single-site study with the goal to enroll 40 patients over the course of the study period All patients that are referred for Pulmonary Artery Reconstruction will be screened for eligibility All patients will undergo standard of care pre-operative hematologic screening to evaluate for bleeding disorders specifically platelet aggregation disorders and acquired von Willebrand Factor deficiency
The study includes a pre-screening period of up to 4 weeks followed by a 12-months follow-up period as part of the standard of care following pulmonary artery reconstruction surgery for children with Alagille syndrome and a research related protocol for children without Alagille syndrome
Patients would have blood drawn one time at least 2 weeks in advance of their cardiothoracic surgery This is the screening protocol to understand if they have a bleeding disorder that would change their management in the operating room and after their surgery For patients that are found to have a bleeding disorder requiring treatment they would need post-operatively a blood test daily for up to 7 days total and another blood test weekly for 2 weeks and then once prior to discharge
Secondary Objectives
1 Develop and implement an intra-operative protocol for children with Alagille syndrome and acquired von willebrand syndrome
2 Compare cardiac intra- and up to 48 hour post-operative bleeding complications post-operative thrombotic complications within 30 days of surgery and mortality for a children with Alagille syndrome with and without acquired von willebrand syndrome and b children without Alagille syndrome
This is a single-site study with the goal to enroll 40 patients over the course of the study period All patients that are referred for Pulmonary Artery Reconstruction will be screened for eligibility All patients will undergo standard of care pre-operative hematologic screening to evaluate for bleeding disorders specifically platelet aggregation disorders and acquired von Willebrand Factor deficiency
The study includes a pre-screening period of up to 4 weeks followed by a 12-months follow-up period as part of the standard of care following pulmonary artery reconstruction surgery for children with Alagille syndrome and a research related protocol for children without Alagille syndrome
Patients would have blood drawn one time at least 2 weeks in advance of their cardiothoracic surgery This is the screening protocol to understand if they have a bleeding disorder that would change their management in the operating room and after their surgery For patients that are found to have a bleeding disorder requiring treatment they would need post-operatively a blood test daily for up to 7 days total and another blood test weekly for 2 weeks and then once prior to discharge
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None