nderstanding Extracorporal Membrane Oxygenation Induced Coaguloapathy – A Prospective Cohort Study in the Intensive Care Unit (EXTRICATE)

Recruiting

• Conditions: In VV-ECMO patients with severe ARDS; in VA-ECMO patients with cardiac arrest during ongoing resuscitation.

• Registration Number: DRKS00033769
• Lead Sponsor: niversität Witten/Herdecke & Klinik Köln Merheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

For VV-ECMO analogous to previous studies:
- severe ARDS according to the Berlin criteria
- PaO2:FiO2 ratio <50 mmHg for >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 <80 mmHg for >6 hours despite the aforementioned measures
- Arterial pH <7.25 with PaCO2 >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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coagulation profile as well as thromboembolic and hemorrhagic complications during ECMO

Secondary Outcome Measures

Name	Time	Method
1. standard coagulation profile (aPTT, Quick/INR, D-dimer, etc.) <br>2. aPC activity <br>3. prothrombin fragment 1.2 (F1.2) concentration<br>4. thrombin-antithrombin (TAT) complex concentration<br>5. endogenous thrombin generation<br>6. thrombelastographic examinations (ROTEM, ROTEM Platelet) <br>7. plasmatic Von Willebrand profile (VW:AG, VW activity, VW multimers) <br>8. microparticle concentration s