Insufficient Cellular Oxygen in ICU Patients With Anaemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-16

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

NCT01172691

Liver Transplant

COMPLETED PHASE2

ORI to Reduce Hyperoxia After Out Hospital Cardiac Arrest

NCT03653325

Out-Of-Hospital Cardiac Arrest Oxygen Toxicity

COMPLETED NA

Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion

NCT02217683

Hypertension, Pulmonary Hemolysis

WITHDRAWN PHASE2

Comparison of Physiological Variables During Blood Donation

NCT02029807

Hemorrhage

COMPLETED

Cerebral Oximetry in Single Lung Ventilation Thoracic Surgery

NCT01866657

Hypoxia

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Care Anemia Erythrocyte Transfusion Oxygen Mitochondria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICU patients with anaemia

At admission to the ICU all patients, or their legal representatives, expected to stay at the ICU for longer than 24 hours will be asked to participate in the study and will be asked informed consent. ICU patients with anaemia in whom a central venous catheter is already in place and in whom a red cell transfusion is planned, will be included in the study.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No