Pathophysiology of Acute Pain in Patients With Sickle Cell Disease (NCT03049475) | Clinical Trial Compass
CompletedNot Applicable
Pathophysiology of Acute Pain in Patients With Sickle Cell Disease
United States99 participantsStarted 2017-03-13
Plain-language summary
Background:
Sickle Cell Disease (SCD) is a blood disorder that occurs mainly in people of African descent. Researchers want to learn more about the painful attacks and complications associated with SCD. They want to look for a relationship between SCD and specific changes in the blood. They want to study the role of genetics, inflammation, and blood clotting factors in SCD. They will do this with blood samples collected during an acute painful attack and in between attacks.
Objective:
To learn more about the painful attacks and complications associated with SCD.
Eligibility:
People ages 18-80 with SCD or who are healthy Africans or African Americans without SCD
Design:
* Participants will be screened with medical history and physical exam.
* Healthy participants will have one visit.
* Participants with SCD will have their first visit when they are not having a pain attack. They will have their next visit during a pain attack. About 3-4 months after this attack, they will have a final visit.
* Visits will include a physical exam, and blood and urine tests.
* Participants may have their blood samples used for genetic testing for research.
Who can participate
Age range
18 Years – 80 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
. Sickle cell disease (all genotypes) with a diagnosis of acute sickle cell pain not related to other cause (if the patient also presents with any other sickle related complication alongside acute sickle pain, including not limited to acute chest syndrome, renal dysfunction, liver dysfunction, stroke and priapism can also be included in the study)
. Between 18 and 80 years of age
. Ability to provide informed written consent
Exclusion criteria
. \<18 years of age
. Pregnancy
. Chronic inflammatory condition (e.g. SLE, Rheumatoid arthritis or any other infectious process leading to chronic inflammation)
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.
1Since this trial is focused on understanding what's happening in my blood during a sickle cell pain crisis — like inflammation and vessel blockage — rather than testing a new treatment, could the findings from this study change how my own pain crises are managed?
2This study compared blood markers during a pain crisis versus a 'steady state' — does my doctor think my own patterns of hemolysis or inflammation might give us useful clues about how to better predict or prevent my crises?
3Since this trial has already been completed, is there published data or results my doctor could share with me so I can understand what the researchers found about the biology of acute pain in sickle cell disease?
4Because this is a pathophysiology study rather than a treatment trial, would participating in or reviewing its findings help inform whether I might be a good candidate for any active treatment trials that target vaso-occlusion or inflammation?
5Given that this study measured specific markers of red cell breakdown and vessel obstruction, are any of those same markers something my care team currently monitors in my routine bloodwork, and if not, should they be?
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
1. To measure and compare defined sets of markers of obstruction of blood vessels (vaso-occlusion), red cell breakdown (hemolysis), and inflammation during acute painful crisis vs steady state in patients with sickle cell disease.
Timeframe: 1 year
Trial details
NCT IDNCT03049475
SponsorNational Heart, Lung, and Blood Institute (NHLBI)