Blood Flow and Pain Crises in People With Sickle Cell Disease (NCT01568710) | Clinical Trial Compass
CompletedNot Applicable
Blood Flow and Pain Crises in People With Sickle Cell Disease
United States94 participantsStarted 2012-03-21
Plain-language summary
Background:
\- Many people with sickle cell disease have repeated episodes of severe pain that lasts for days, requiring hospital care. These episodes, called pain crises, may be caused by changes in blood flow. Researchers want to study blood flow in people with sickle cell disease who are having a pain crisis and compare it with their blood flow after the pain crisis has resolved. They also want to compare these measurements against blood flow in healthy people who do not have sickle cell disease.
Objectives:
\- To study whether changes in blood flow cause pain crises in people with sickle cell disease.
Eligibility:
* Individuals at least 18 years of age who have sickle cell disease and are being treated for a pain crisis.
* Individuals at least 18 years of age who have sickle cell disease and are not experiencing a pain crisis.
* Healthy volunteers matched by age and gender with the participants who have sickle cell disease.
Design:
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
* Participants having a sickle cell pain crisis will have two visits, one during the crisis and one about 4 weeks after the crisis has resolved.
* Participants not having a sickle cell pain crisis will have one or two study visits. Blood samples will be collected during at least one of these visits.
* Healthy volunteers will have one or two study visits. Blood samples will be collected during at least one of these visits.
* During each visit for all participants, cameras and blood flow monitoring equipment will be used to measure blood flow in the forearm.
sickle cell disease.
Who can participate
Age range
18 Years – 99 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
. Age 18 years or older.
. Diagnosis of sickle cell anemia:
. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).
. Acute onset pain crisis in a distribution typical for that subject, onset within the last 7 days and for which hospitalization and parenteral narcotic pain treatment are required.
. Ability to provide informed written consent.
Exclusion criteria
. Pregnancy.
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.
Trial details
NCT IDNCT01568710
SponsorNational Heart, Lung, and Blood Institute (NHLBI)