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The T-REX study: developing a laboratory test for investigating oxidative stress in red blood cells in patients with a rare anemia

Developing a laboratory technique to measure the sensitivity of red blood cells to oxidative stress based on their deformability in patients with rare anemias – the T-REX study - T-REX

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58122
Enrollment
240
Registered
2025-07-31
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassemia, sickle cell disease, hemoglobinopathies, hereditary hemolytic anemias Thalassemia, sickle cell disease, inherited blood disorders/anemia

Interventions

The intervention involves a blood draw of 40 milliliters.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
16 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adolescents and adults, =16 years oldParticipant diagnosed with thalassemia, sickle cell disease (SCD) or another form of hereditary hemolytic anemia (HHA).In case of thalassemia or SCD: diagnosis has been established via electrophoresis, HPLC and/or DNA analysis.In case of any other HHA: diagnosis has been established via morphological analysis, osmotic gradient ektacytometry, the osmotic fragility test, the EMA-binding test, determination of spectrin levels, measurement of enzymatic activity and thermostability, and/or DNA analysis, depending on the appropriate test for each specific disease.Participant is willing and able to give informed consent

Exclusion criteria

Exclusion criteria: Children, <16 years oldWomen who are pregnantRecent blood transfusion (within three months prior to blood withdrawal)*Patients with current/active infection*With the exception of transfusion-dependent thalassemia patients 

Design outcomes

Primary

MeasureTime frame
Optimizing oxidant-ektacytometry conditions to improve the discrimination of thalassemia patients, to gain insight into the susceptibility of RBCs to exogenous oxidative stress across different genetic subgroups of thalassemia. 

Secondary

MeasureTime frame
Optimizing oxidant-ektacytometry conditions (type of oxidant) to improve the discrimination of SCD patients, to gain insight into the susceptibility of RBCs to exogenous oxidative stress across different genetic subgroups of sickle cell disease. To explore how different oxidants and anti-oxidants affect results of oxidant-ektacytometry.To explore the association of oxidant-ektacytometry measurements with clinical symptoms and condition, hematological parameters, markers of hemolysis, markers of inflammation, and other markers of oxidative stress (e.g. antioxidative enzyme activity, non-enzymatic antioxidants, protein oxidation, lipid peroxidation, reactive oxygen species).

Countries

Netherlands

Contacts

Public ContactM.A.E. Rab

Erasmus MC, Universitair Medisch Centrum Rotterdam

secretariaat.hematologie@erasmusmc.nl010-7033123

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)