Skip to main content
Clinical Trials/DRKS00033769
DRKS00033769
Recruiting
Not Applicable

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

niversität Witten/Herdecke & Klinik Köln Merheim0 sites50 target enrollmentFebruary 29, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
In VV-ECMO patients with severe ARDS
Sponsor
niversität Witten/Herdecke & Klinik Köln Merheim
Enrollment
50
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 29, 2024
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversität Witten/Herdecke & Klinik Köln Merheim

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials