This study has been transitioned to CTIS with ID 2023-509675-16-01 check the CTIS register for the current data. Our objective is to study if reduced anticoagulation targets diminish bleeding complications without an increase in thromboembolic…
ID
Source
Brief title
Condition
- Heart failures
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is a combined endpoint consisting of: 1) major
bleeding including hemorrhagic stroke according to the ELSO definitions; 2)
severe thromboembolic complication defined as ischemic stroke, limb ischemia
(not related with distal perfusion catheter), or acute pump failure with
emergency exchange; 3) mortality at 6 months.
Secondary outcome
Secondary outcome parameters are: 1) blood transfusions; 2) health related
quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator;
4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary
embolism; 6) costs; 7) the individual components of the composite outcome; and
8) all thromboembolic complications combined.
Background summary
ECMO treatment has a mortality of 38%, for a large part treatment related due
to complications. The most feared complication is ischemic stroke for which
heparin is administered with an aPTT target 2.0-2.5 times baseline
(approximately 60-75 sec).
However, there is no relation between aPTT and the occurrence of stroke (1.2%),
but there is a relation with the much more frequent occurrence of bleeding
complications (55%) and blood transfusion. Both are strongly related to
outcome.
Study objective
This study has been transitioned to CTIS with ID 2023-509675-16-01 check the CTIS register for the current data.
Our objective is to study if reduced anticoagulation targets diminish bleeding
complications without an increase in thromboembolic complications or a negative
impact on outcome.
Study design
Three-arm non-inferiority RCT.
Intervention
Randomization between heparin administration with a target of 2-2.5 times
baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0 times baseline aPTT
(45-60 sec.) or low molecular weight heparin (LMWH) guided by weight and renal
function.
Study burden and risks
We estimate that with an aPTT target of 45-60 sec. or with use of LMWH the
primary endpoint will be met in 60% of patients compared to 70% with usual
care. To show non-inferiority 91 patients per group are needed. To compensate
for a lower effect and drop-outs 330 patients will be enrolled. Results will be
analyzed by intention to treat.
Apart from anticoagulation targets, treatment will be as usual so study
participation will not lead to a burden for the patient, e.g. no extra blood
sampling, tests or visits. After 6 months the patients will be contacted for a
short questionnaire to measure health-related quality of life. A risk may be
that reduced anticoagulation target or anticoagulation with LMWH is inferior to
standard practice. A benefit may be that reduced anticoagulation target or
anticoagulation with LMWH is superior to standard practice.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
Adults treated with ECMO for heart or lungfailure
Exclusion criteria
• Patients in whom the ECMO is only used to bridge a procedure like a high risk
percutaneous coronary intervention or during surgery
• Vital indication for robust anticoagulation (e.g. mechanic mitral valve,
pulmonary embolism, clot in cardiac ventricle)
• History of heparin induced thrombocytopenia (HIT)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-509675-16-01 |
| EudraCT | EUCTR2019-004125-24-NL |
| Other | NL 7969 |
| CCMO | NL71811.042.20 |