Low VW Activity in Adolescent HMB (Low VWF)

Baylor College of Medicine

Status

Active, not recruiting

Conditions

Von Willebrand Factor Deficiency

Treatments

Other: Medical Record Data Abstraction

Other: Pictorial Blood Assessment Chart (PBAC) score

Other: Complete Bleeding Symptom ISTH Bleeding Assessment Tool

Other: Genetic Analysis

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02933411

H-39295 LOW VWF

Details and patient eligibility

About

This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge of blood and tissues from the uterus. HMB is having a heavier amount of discharge during menstrual period. Low Von Willebrand Factor means that the participant has lower level of a blood protein that is important for clotting of blood and so, the participant is at a higher risk for bleeding.

The purpose of this project is to study the genetic differences of adolescent females with HMB and low VWF activity and compare the genetic differences with their bleeding manifestations, response to medications and outcome.

Full description

One hundred and twenty subjects will be enrolled. Adolescent females with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF) will be recruited.

Data collection will occur from participant's medical records in regards to their low VWF activity and HMB medical history.

Participants will be asked to complete symptom questionnaires in regards to their HMB.

A blood sample will be collected to analyze how many participants have the disease causing sequence variation in the VWF gene and other genes affecting bleeding, clotting and blood vessel biology and correlated with their bleeding history.

The blood sample will be deidentified and stored indefinitely for future research.

Enrollment

120 estimated patients

Sex

Female

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Post-menarchal females less than 21 years of age
HMB defined as PBAC score greater than 100
VWF:Activity more than or equal to 30 and less than or equal to 50 IU/dL x 2
VWF: Activity /VWF:Ag ratio greater than or equal to 0.6
Normal VW multimers, if performed

Exclusion criteria

Post menarchal females age greater than or equal to 21 years
VWF: Activity less than 30 or greater than 50 IU/dL consistently, type 2 or type 3 VWD
Presence of other bleeding disorders (thrombocytopenia, platelet function defect, coagulation factor deficiency, fibrinogen defect or deficiency)