DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— DIC-ECMO  

Official title:

DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095518
• Other study ID #: UW 23-259
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Queen Mary Hospital, Hong Kong
• Contact: Wincy Ng
• Phone: +852-22553111
• Email: wincyngwingsze[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Age ? 18; AND
• Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
• Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.

Exclusion Criteria:

• Patients who are on central VA-ECMO support; OR
• Patients with missing clinical data; OR
• Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
• Post-operative admissions

Related Conditions & MeSH terms

• Extracorporeal Circulation; Complications
• Extracorporeal Membrane Oxygenation Complication

Intervention

Diagnostic Test:
• DIC markers and Thrombin Generation Parameters
Observation of DIC markers and thrombin generation parameters in patients with and without thrombotic and hemorrhagic complications

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of thrombotic and hemorrhagic events	Thrombotic events include circuit-related thrombosis (e.g. oxygenator failure requiring circuit change) OR Non-circuit-related thrombosis (e.g. new pulmonary embolism or deep vein thrombosis while on ECMO.; Hemorrhagic events include bleeding at critical sites or requiring interventions.	From the start of ECMO support to the end of ECMO support (which can be variable, typically around 5 days to 1 week)