The study will compare the change in cutaneous cellular oxygen availability, measured as mitochondrial PO2 (mitoPO2) between a fluid challenge and a blood transfusion in chronic anemia patients.
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is cellular oxygen availability in skin
(mitoPO2 in mmHg) and its differential response to RBC transfusion compared to
fluid challenge.
Secondary outcome
* Determine the cutaneous oxygen availability in relation to Hb level before
and after a fluid challenge of 500 ml of normal saline.
* Determine the cutaneous oxygen availability in relation to Hb level before
and after a blood transfusion.
* Determine the change in cutaneous oxygen availability by a fluid challenge of
500 ml of normal saline.
* Determine the change in cutaneous oxygen availability by a blood transfusion.
* Explore the clinical usability of the COMET monitor in blood transfusion
treatments.
Background summary
To date no appropriate measurement technique exists to determine when the
benefits of a red blood cell transfusion outweigh the transfusion related risks
on an individual level. The preclinical finding that anemia-induced low
Mitochondrial Oxygen Tension Improves not upon Fluid Administration but after
Transfusion of Erythrocytes (MOTIFATE) is a key principle in our quest for a
novel transfusion trigger. Demonstrating that the MOTIFATE principle also
accounts to humans is a necessary first step in further clinical evaluation of
the use of mitochondrial oxygen tension (mitoPO2) in personalized transfusion
medicine. In this pilot study we want to research the MOTIFATE principle in a
low-risk patient population consisting of hematological chronic anemia
patients.
Study objective
The study will compare the change in cutaneous cellular oxygen availability,
measured as mitochondrial PO2 (mitoPO2) between a fluid challenge and a blood
transfusion in chronic anemia patients.
Study design
Single centre non-blinded randomized controlled trial.
Study burden and risks
The intracellular oxygen measurement is a non-invasive measurement technique
and does not lead to deviations from standard protocols. The specific
discomfort for the patient is that an aminolevulic acid containing-plaster is
applied which makes the skin sensitive for light. This plaster is applied at
least 4 hours before a measurement can be done. The measurement device is
called the COMET monitor, able to measure cutaneous mitoPO2 and mitochondrial
oxygen consumption (mitoVO2) by means of oxygen-dependent quenching of delayed
fluorescence of mitochondrial protoporphyrin IX. The additional fluid challenge
of 500 ml pre-warmed saline should be very well tolerable for adult patients
without heart or kidney failure. Overall, the study comes with a negligible
risk and the burden is very low.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
* Be scheduled to receive a blood transfusion
* Has a Hb level below the value indicated for red blood cell transfusion according to current transfusion guidelines for chronic anemia or
* Has a Hb level above the value indicated for red blood cell transfusion according to current transfusion guidelines but presents with clinical symptoms of (too) low Hb (e.g. fatigue and general malaise).
Exclusion criteria
* Age < 18 years
* History or signs of heart failure
* Kidney failure with fluid restriction
* Porphyria
* Hemoglobinopathy
o Hemoglobin C disease
o Hemoglobin S-C disease
o Thalassemia
o Sickle cell anemia
Design
Recruitment
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 |
|---|---|
| CCMO | NL55664.078.15 |