Validation TAP-100 blood collection device

Validation TAP-100 blood collection device - TAP-100 blood collection device

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48781

Enrollment

Registered

2019-11-14

Start date

2020-11-06

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

blood coagulation disorders Hemophilia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for healthy subjects: 20 years or older, no known (co)morbidities. Inclusion criteria patients: To have severe hemophilia A and 20 years or older.

Exclusion criteria

Exclusion criteria: A healthy volunteer who meets any of the following criteria will be excluded from participation in this study: - use of anticoagulants or platelet antagonists (aspirin or any TAR) - pregnancy A hemophilia A patient who meets any of the following criteria will be excluded from participation in this study: - use of anticoagulants or platelet antagonists (aspirin or any TAR) - trauma or surgery within the last two weeks, - a bleeding episode within the last two weeks - clinical indication of liver cirrhosis (echographic indication, enlarged spleen, enlarged liver, decreased platelet count)

Design outcomes

Primary

Measure	Time frame
The following biomakers will be analyzed in the different samples. A) Full length Tissue Factor antigen levels B) Prothrombin F1+2 C) D-dimer D) Factor VIII antigen and activity levels	—

Secondary

Measure	Time frame
Blood volume obtained Time of collection Reaction of skin and bruises etc.	—

Countries

Netherlands

Outcome results