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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014959

Enrollment

100

Registered

2019-10-01

Start date

2023-02-15

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J96.0 I50.0 I50.1

Interventions

Group 1: Measurement of coagulation parameters during ECLS (timepoint 0, 24h and 5 d post ECLS-start)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - patients with known bleeding disorders

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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) - 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) - Measurement of CRP, D-Dimer (Blood sampling before, 24h and 5 days after ECLS start) plus daily routine parameters 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.	—

Measure

Time frame

- 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) - 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) - Measurement of CRP, D-Dimer (Blood sampling before, 24h and 5 days after ECLS start) plus daily routine parameters 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.

—

Countries

Germany

Contacts

Public ContactWolfgang Miesbach

Hämophiliezentrum, Institut für Transfusionsmedizin, Medizinische Klinik III, Goethe Universitätsklinikum

wolfgang.miesbach@kgu.de06963015051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026