Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04466878
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-07-06
Brief Title:
Prognostic Value of Implementing VCE on Top in Constitutional VWD-patients With GI-bleeding
Sponsor:
University Hospital Lille
Organization:
University Hospital Lille
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Inclusion criteria Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included Patients with acquired von Willebrand syndrome will not be included
Material and Methods A 15-items survey that will be sent to the 30 centers involved in the French network for bleeding disorders MHEMO to identify VWD-patients referred for endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017 Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included Constitutional VWD diagnosis will be confirmed confirmed centrally in all patients by the French reference center for von Willebrand disease A GI-bleeding episode will be defined as any overt or occult GI-bleeding unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 gdL from baseline We will analyze patient characteristics GI-bleeding pattern VWD typesubtype nature gastroscopy colonoscopy or VCE and results of the endoscopic exploration and management that was applied endoscopic therapy by argon plasma coagulation on-demandprophylactic-VWF replacement therapy use of antiangiogenic drugs If angiodysplasia without another bleeding source is identified GI-bleeding will be categorized as angiodysplasia if another lesion is identified GI-bleeding will be categorized as no-angiodysplasia and if no bleeding source is identified GI-bleeding will be categorized as obscure GI-bleeding Recurrence will be defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 gdL from baseline
Material and Methods A 15-items survey that will be sent to the 30 centers involved in the French network for bleeding disorders MHEMO to identify VWD-patients referred for endoscopic exploration of at least one GI-bleeding from January 2015 to December 2017 Only constitutional VWD-patients fulfilling the inclusion criteria of the French reference center for VWD will be included Constitutional VWD diagnosis will be confirmed confirmed centrally in all patients by the French reference center for von Willebrand disease A GI-bleeding episode will be defined as any overt or occult GI-bleeding unexplained chronic iron deficiency anemia causing a drop of hemoglobin level by more than 2 gdL from baseline We will analyze patient characteristics GI-bleeding pattern VWD typesubtype nature gastroscopy colonoscopy or VCE and results of the endoscopic exploration and management that was applied endoscopic therapy by argon plasma coagulation on-demandprophylactic-VWF replacement therapy use of antiangiogenic drugs If angiodysplasia without another bleeding source is identified GI-bleeding will be categorized as angiodysplasia if another lesion is identified GI-bleeding will be categorized as no-angiodysplasia and if no bleeding source is identified GI-bleeding will be categorized as obscure GI-bleeding Recurrence will be defined as evidence of overt GI-bleeding or a drop of hemoglobin level by more than 2 gdL from baseline
Detailed Description:
None
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