Osteogenesis Imperfecta Blood Pressure Study (NCT04169568) | Clinical Trial Compass
CompletedNot Applicable
Osteogenesis Imperfecta Blood Pressure Study
United States50 participantsStarted 2019-11-15
Plain-language summary
Osteogenesis Imperfecta (OI) is a genetic disorder caused by mutations to the alpha-1 or alpha-2 chain of type I collagen. Clinically, the disorder is characterized by bones that fracture easily, often from little or no apparent trauma. There is no information about Some institutions perform blood pressure monitoring on these patients with a cuff, while other institutions avoid this method due to concern for fracture. Instead, they use alternative forms of monitoring such as an arterial line. These methods come with their own risks, including clotting, decreased perfusion, and pain. In addition, arterial lines require intensive (and more expensive) monitoring in a pediatric intensive care unit due to risk of dislodgement and rapid blood loss. These blood pressure monitoring recommendations for patients with OI do not appear to be based on strong evidence. Anecdotally, some patients and healthcare professionals report hearing about individuals with OI who have suffered fractures from blood pressure cuffs. However, this is not well documented in the medical literature. Regular and accurate blood pressure monitoring is particularly important in the postoperative period, due to blood loss and fluid shifts, as well as utilization of advanced pain management techniques that can potentially impact blood pressure.
Who can participate
Age range
1 Year – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with OI who are undergoing extremity surgery or spinal fusion surgery.
* Patients between the ages of 1 and 35 years with OI who are admitted at our institution to a non-ICU inpatient setting in the postoperative period following an orthopedic surgery.
* Patients who initially require ICU-level care but transition to a non-ICU setting following an orthopedic surgery.
* Recent fracture in contralateral upper extremity (\< 8 weeks, or upper extremity fracture that is not yet completely healed).
* Must be able to tolerate upper extremity blood pressures.
* Medical clearance by OI physicians (Kruse, Franzone) after review of fracture history, surgical procedures, x-rays.
Exclusion Criteria:
* Parent or child refusal, uncooperative child.
* History of frequent upper extremity fracture on ipsilateral side, or recent upper extremity fracture on ipsilateral side if only that side may be used.
* Clinical presence of thrombocytopenia (excessive or easy bleeding or bruising), admission or transfer to PICU.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sphygmomanometer blood pressures
Timeframe: Every 4 hours for first 24 hours, then every 8 hours until discharge