Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455553
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-06-04
Brief Title:
Interpretability of the Quantra Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50x10 GL
Sponsor:
Centre Hospitalier Annecy Genevois
Organization:
Centre Hospitalier Annecy Genevois
Study Overview
Official Title:
Interpretability of the Quantra Viscoelastic Test in Patients With Haematological Malignancies With Profound Thrombocytopenia Below 50 GL First Exploratory Sub-study of the Global VISCOTHEM Project to Evaluate the Performance of VISCOelastic Tests in Predicting Bleeding in Thrombocytopenic Patients With Malignant Hemopathy
Status:
RECRUITING
Status Verified Date:
2024-08
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:
VISCOTHEM-1
Brief Summary:
The goal of this single-center non-controlled non-randomized exploratory clinical trial is to evaluate the interpretability of viscoelastic tests Quantra and ROTEM type in relation to platelet levels measured in standard biology in patients with haematological malignancies hospitalized in day hospitals or full hematology wards presenting thrombocytopenia strictly below 50 GL
Participants will undergo an additional blood sample to standard care The total volume of blood drawn will be 121 mL The following analyses will be performed Quantra Rotem blood count platelets immature platelet count plasma prothrombin time activated partial thromboplastin time International Normalized Ratio fibrinogen
Participants will undergo an additional blood sample to standard care The total volume of blood drawn will be 121 mL The following analyses will be performed Quantra Rotem blood count platelets immature platelet count plasma prothrombin time activated partial thromboplastin time International Normalized Ratio fibrinogen
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