In VV-ECMO patients with severe ARDS
Conditions
Interventions
Group 1: Coagulation profile of patients on venovenous or venoarterial extracorporeal membrane oxygenation (ECMO)
Sponsors
Universität Witten/Herdecke & Klinik Köln Merheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For VV-ECMO analogous to previous studies: - severe ARDS according to the Berlin criteria - PaO2:FiO2 ratio 3 hours despite optimization of mechanical ventilation [FiO2 =80%, tidal volume = 6 ml per kg of ideal body weight and positive end-expiratory pressure (PEEP) =10 cm H2O) and despite the use of adjuvant therapeutic measures (e.g. inhaled nitric oxide therapy, recruitment maneuver, ventilation in prone position)] - PaO2:FIO2 ratio 6 hours despite the aforementioned measures - Arterial pH 60 mmHg for >6 hours under ventilator settings with a plateau pressure =32 cm H2O For VA-ECMO analogous to previous studies: - Observed collapse with no-flow time < 5 min and low-flow time < 90 min on arrival in the cardiac catheter - Initial and sustained defibrillable rhythm or non-defibrillable rhythm in case of tamponade or pulmonary artery embolism (exception: accidental hypothermia or intoxication)
Exclusion criteria
Exclusion criteria: 1. pregnancy 2. patient moribund or with "Simplified Acute Physiology Score" value >90 3. underlying malignancy with life expectancy < 5 years 4. irreversible neurological damage 5. decision to limit therapy 6. ventilation for longer than 7 days (for vv-ECMO) 7. chronic lung disease and chronic respiratory respiratory insufficiency with home oxygen therapy (for vv-ECMO) 8. history of heparin-induced thrombocytopenia or other contraindication to heparin 9. hereditary thrombophilia or hemophilia 10. therapeutic anticoagulation or dual platelet inhibition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coagulation profile as well as thromboembolic and hemorrhagic complications during ECMO | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. standard coagulation profile (aPTT, Quick/INR, D-dimer, etc.) 2. aPC activity 3. prothrombin fragment 1.2 (F1.2) concentration 4. thrombin-antithrombin (TAT) complex concentration 5. endogenous thrombin generation 6. thrombelastographic examinations (ROTEM, ROTEM Platelet) 7. plasmatic Von Willebrand profile (VW:AG, VW activity, VW multimers) 8. microparticle concentration s | — |
Countries
Germany
Contacts
Public ContactJan-Hendrik Naendrup
Universität Witten/Herdecke & Uniklinik Köln
Outcome results
None listed