Investigation on bleeding and coagulation parameters in patients with extracorporeal life support (ECLS) device

Recruiting

• Conditions: J96.0; I50.0; I50.1; Acute respiratory failure; Congestive heart failure; Left ventricular failure

• Registration Number: DRKS00014959
• Lead Sponsor: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with indication for ECLS because of acute cardiac and/or pulmonary failure

Exclusion Criteria

- patients with known bleeding disorders

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of course von Willebrand parameters: vWF antigen (VWF:Ag), vWF activity (VWF:Act), vW-ratio, von Willebrand multimers during ECLS treatment (Blood sampling before, 24h and 5 days after start of ECLS)

Secondary Outcome Measures

Name	Time	Method
- Determination of haemoglobin, platelet count, PT, PTT, , Factor VIII, Factor XII, determination of the function of thrombocytes, Factor XIII and thrombin generation (blood sampling before, 24 h and 5 days after ECLS start)<br>- Measurement of further coagulation-related parameters such as fibrinogen, International Normalized Ratio (INR), heparin monitoring (aPTT and Factor aXa) (blood sampling before, 24h and 5 days after ECLS start)<br>- Measurement of CRP, D-Dimer (Blood sampling before, 24h and 5 days after ECLS start)<br><br>plus daily routine parameters<br><br>Additionally documentation of bleeding anamnesis and risk, bleeding and thrombosis events during ECLS and therapy. Follow up of morbidity/mortality 2 and 5 years post ECLS.