Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07454161
Eligibility Criteria:
Inclusion Criteria:
* Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.
* Increased bleeding tendency based on: Abnormal ISTH-BAT score (≥ 5 in women age 18-30; ≥ 6 in women age 31-51, ≥ 7 in women age 52 or older; ≥4 in men and ≥ 3 in children) OR Clinical gestalt according to the investigating physician
* Absence of diagnostic test results for a bleeding disorder in standard laboratory hemostasis tests:
* Complete blood count: Hemoglobin \> 6.0 mmol/L; thrombocyte count \> 100 x10\^9/L
* PT and aPTT: within local reference range, or prolonged without explanatory factor deficiency
* Fibrinogen activity, VWF antigen \& activity, Factor VIII, IX, XI and XIII: within local reference range or abnormal but not explaining bleeding phenotype
* Light transmission aggregometry: Not diagnostic for a platelet function
* Kidney function: EGFR \> 45 ml/min
* Liver function: ALAT, bilirubin \< 3 x ULN
Exclusion Criteria:
* Use of medication interfering with laboratory hemostasis tests which cannot be stopped before blood withdrawal (e.g. anticoagulant or antiplatelet therapy, NSAID's, SSRI's)
* Pregnancy or lactation at moment of inclusion
* Presence of a known bleeding disorder
* Presence of an acquired cause or another explanation for the increased bleeding tendency
* Inability to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT07454161
Study Brief:
Protocol Section:
NCT07454161