Anticoagulation Effects on Quality of Life in Patients with Slow-flow Vascular Malformations

R
Rachael Schulte

Primary Investigator

Overview

This study is being done to learn more about how being on anticoagulation therapy (blood thinners) affects the quality of life of patients with vascular malformations (for example, how this therapy affects pain and ability to do daily tasks). A vascular malformation is an abnormal collection of blood or lymphatic vessels that is something people are born with, and anticoagulation is sometimes be used to manage symptoms from vascular malformations.

Description

Participants will have visits with their doctor at baseline (before starting the blood thinner) and then 2 weeks, 4 weeks, and 12 weeks later. Their doctor will talk to them about how often visits or blood draws will be required as part of standard treatment, outside of this study. At each scheduled visit, participants will fill out a survey about your health, activity, and emotional and social functioning. Participants can agree to have extra blood drawn for this study. Their blood will be drawn twice during study participation: at baseline before starting the blood thinner and 4 weeks after starting or changing the type of blood thinner your doctor prescribes. We will make every attempt to collect this during regularly scheduled labs. 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Vascular malformation
  • Age: Between 2 Years - 99 Years
  • Gender: All

Inclusion Criteria:
  • Presence of a slow-flow vascular malformation
  • Determined to need and eligible for anticoagulation therapy at the discretion of the treating physician per standard of care
  • Informed consent provided, and if applicable, child assent provided
Exclusion Criteria:
  • Provider plans to initiate LMWH or DOAC only for peri-procedural anticoagulation 
  • Patient has been on sirolimus for <3 months or provider plans to initiate sirolimus in next 3 months
  • Received LMWH, DOAC, or aspirin within the last 30 days prior to baseline visit.

Updated on 05 May 2024. Study ID: 16920, PHO-ACH-SLOW-FLOW
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