Overview
Sponsor-declared trial summary
All patients who receive ECMO treatment during the study period in one the participating centers from which (deferred) informed consent is obtained. Patients in whom the ECMO is only used to bridge a procedure like a high risk percutaneous coronary intervention or during surgery are excluded.
Our primary research question is if anticoagulation with UFH with reduced anticoagulation targets or anticoagulation with low molecular weight heparin (LMWH) leads to a reduction in the occurrence of major bleeding without an increase in thromboembolic complications or a negative effect on outcome compared to the stand…
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-509675-16-01
- EudraCT number
- 2019-004125-24
- ClinicalTrials.gov
- NCT00412524
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
Our primary research question is if anticoagulation with UFH with reduced anticoagulation targets or anticoagulation with low molecular weight heparin (LMWH) leads to a reduction in the occurrence of major bleeding without an increase in thromboembolic complications or a negative effect on outcome compared to the standard practice of high anticoagulation targets with UFH. We expect fewer complications and improvement of survival after ECMO therapy for both interventions.
Conditions and MedDRA coding
All patients who receive ECMO treatment during the study period in one the participating centers from which (deferred) informed consent is obtained. Patients in whom the ECMO is only used to bridge a procedure like a high risk percutaneous coronary intervention or during surgery are excluded.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509675-16-00 | Reduced anticoagulation targets in extracorporeal life support | Universitair Medisch Centrum Groningen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All adults receiving ECMO treatment at the ICU of one of the participating centers during the study period are eligible for inclusion.
Exclusion criteria 1
- The exclusion criteria are as follows: (1) patients in whom the ECMO is only used to bridge a procedure like a high-risk percutaneous coronary intervention or during surgery; (2) no (deferred) informed consent; (3) vital indication for robust anticoagulation (e.g., mechanic mitral valve, pulmonary embolism, a clot in the cardiac ventricle); and (4) a history of heparin-induced thrombocytopenia (HIT).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP100373670 · ATC
- Active substance
- Heparin
- Substance synonyms
- HEPARIINI, HEPARINUM
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 IU/Kg iu/kilogram
- Max total dose
- 109500 IU/Kg iu/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB01 — HEPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP101882242 · ATC
- Active substance
- Nadroparin Calcium
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 192 IU/Kg iu/kilogram
- Max total dose
- 35040 IU/Kg iu/kilogram
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB06 — NADROPARIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Walter M. van den Bergh
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Olivier van Minnen
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 330 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2023-509675-16-01 Protocol-RATE FINAL | 1.2 |
| Recruitment arrangements (for publication) | Recruitment procedure and first act of recruitment | 1 |
| Subject information and informed consent form (for publication) | E1 en E2 PIF pat na IC wett vert RATE v13 | 1.3 |
| Subject information and informed consent form (for publication) | E1 en E2 PIF wett vert RATE v13 | 1.3 |
| Summary of Product Characteristics (SmPC) (for publication) | D2 SmPC heparine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | D2 SmPC nadroparine | 1 |
| Synopsis of the protocol (for publication) | Summary RATE protocol | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Netherlands | Acceptable with conditions 2025-01-28
|
2025-01-28 |