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Comparison of Ideal vs. Actual Weight Base Factor Dosing

NCT03286153 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-18

No results posted yet for this study

Summary

This is a randomized, prospective, multicenter study to examine whether or not the current recommended factor dosing strategy - i.e., dosing by actual body weight - in overweight and obese patients with Hemophilia A may deliver excessive clotting factor to achieve the desired result of bleeding prevention and cessation. This study also examines ways to prevent delivering excessive factor by using a patient's ideal body weight as a new dosing strategy compared to the current dosing strategy. The hypothesis being tested is that factor dosing based on ideal body weight will result in protective factor levels.

Conditions

Interventions

OTHER

Ideal Body Weight First

Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on ideal body weight. For participants age 12-19, ideal weight is calculated using the McLaren method. For participants age 20 and over, ideal weight is calculated using the following equation: \[50kg + (2.3kg\*every inch over 5 feet)\].

OTHER

Actual Body Weight First

Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.

Sponsors & Collaborators

  • Seattle Children's Hospital

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Providence Health & Services

    collaborator OTHER

  • Bloodworks

    lead OTHER

Principal Investigators

  • Rebecca Kruse-Jarres, MD, MPH · Washington Center for Bleeding Disorders at Bloodworks Northwest

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286153 on ClinicalTrials.gov