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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03092297
Other study ID # NL59512.058.16
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date May 16, 2017
Est. completion date December 1, 2022

Study information

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

Clinical Trial Summary

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.


Description:

Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. New studies have shown the potential of protoporphyrin IX-triple state lifetime technique to measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is an early indicator of oxygen disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing the effects of red cell transfusion and the associated change in [Hb] on mitoPO2 and on other physiologic measures of tissue oxygenation and oxygen balance 3. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place. The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Netherlands Amsterdam Medical Center Amsterdam Amsterdam-Zuidoost, Noord-Holland
Netherlands Leiden University Medical Center Leiden Zuid-Holland

Sponsors (4)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

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
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