Anemia Clinical Trial
— INOX ICU-2Official title:
Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
Verified date | December 2022 |
Source | Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.
Status | Terminated |
Enrollment | 103 |
Est. completion date | December 1, 2022 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult patient admitted to the ICU - Hb below 6.3 mmol/l (10 g/dl) - central venous catheter in situ - red cell transfusion planned Exclusion Criteria: - adults without a legal representative to ask for informed consent - patients less than 18 years old - pregnant or breast feeding women - patients in need of emergency red cell transfusion e.g. bleeding - not having a central venous catheter in situ - porphyria and or known photodermatosis - patients with an expected ICU stay <24 hours - patients with hypersensitivity to the active substance or to the plaster material of ALA |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam Medical Center | Amsterdam | Amsterdam-Zuidoost, Noord-Holland |
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center, Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variability of mitoPO2 | Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance. | Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study | |
Secondary | Organ damage | Value of mitoPO2 measurements for predicting (ischemic) organ damage | Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study | |
Secondary | Microcirculation | Association of mitoPO2 with the microcirculation | Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study | |
Secondary | Length of stay | Length of hospital-stay and ICu stay | Length of stay will be assessed during the 3 months follow-up time | |
Secondary | Mortality | 90-day mortality, hospital mortality and ICU mortality | Mortality will be assessed during the 3 months follow-up time | |
Secondary | Adverse events | Adverse and serious adverse events of the mitoPO2 measurements | Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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