In vitro determination of optimal dose of factor substitution treatment in haemophilia patients using thrombin generation on ST Genesia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014357

Enrollment

Registered

2018-10-17

Start date

2019-08-22

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

D66 D67

Interventions

Group 1: Patients with severe Haemophilia A or B and regular factor prophylaxis: Blood samples will be collected pre regular factor infusion (sample 1: 4x3.8ml) and 60 min post infusion (sample 2= exp

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: severe haemophilia A or B and factor prophylaxis

Exclusion criteria

Exclusion criteria: no factor prophylaxis, no informed consent

Design outcomes

Primary

Measure	Time frame
thrombin generation in ex vivo patient blood sample (TG Assay): time point 1) pre infusion of substitution factor, in vitro sample spiked with equivalent concentration of factor concentrate; time point 2) 60 min post infusion of substitution factor	—

Secondary

Measure	Time frame
Thrombin generation assay in ex vivo patient sample post in vitro spiking with different factor doses => determination of optimal factor dose	—

Countries

Germany

Contacts

Public ContactWolfgang Miesbach

Hämophiliezentrum, Institut für Transfusionsmedizin, Medizinische Klinik III, Goethe Universitätsklinikum

wolfgang.miesbach@kgu.de06963015051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026