Coagulation monitoring to prevent hemostatic complications in kids on extracorporeal membrane oxygenatio

Completed

• Conditions: coagulation in children on heart-lung machine; 10064477; 10082206; 10024967

• Registration Number: NL-OMON52557
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Children from 0 to 17 years old treated on ECMO in the participating ECMO
centers can be included in this study.

Exclusion Criteria

1. Patients without informed consent
2. Patients after 24 hours of start of ECMO

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The first bleeding complication or the first clotting complication in the<br /><br>first 14 days of ECMO therapy<br /><br><br /><br>2. Test results of coagulation tests including ACT, APTT, PT, anti-Xa,<br /><br>fibrinogen, D-dimer, platelets, VWF act, VWF ag, VWF-CB, VWF multimers, ROTEM<br /><br>(time to clot initiation: clotting time [CT] in EXTEM and INTEM; clot strength:<br /><br>maximum clot firmness [MCF] in EXTEM and INTEM; fibrinogen activity: MCF in<br /><br>FIBTEM; and heparin effect: CT in HEPTEM and INTEM); fibrinolysis (LY 30 in<br /><br>EXTEM and INTEM), TEG (R in EXTEM and INTEM; MA in EXTEM and INTEM; MA in<br /><br>FIBTEM; R in HEPTEM and INTEM; CL30 in EXTEM and INTEM), and TGA (ETP).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Test results of coagulation tests over time during the first 14 days of ECMO<br /><br>therapy<br /><br>2. The total number of bleeding and clotting complications in the first 14 days<br /><br>of ECMO<br /><br>3. Survival of children with and without hemostatic complications during ECMO<br /><br>in the first 14 days of ECMO</p><br>