NCT01441141

Genetics and Pain Severity in Sickle Cell Disease

Completed Last updated 10 December 2020

What this trial tests

trial in Genotype in 67 participants. Completed in 9 December 2020.

Timeline

17 June 2012

Primary endpoint
31 May 2016

9 December 2020

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	67
Start date	17 June 2012
Primary completion	31 May 2016
Estimated completion	9 December 2020
Sites	1 location across United States

Conditions studied

• Genotype — all drugs for Genotype →
• Pain — all drugs for Pain →
• Genetic Variation — all drugs for Genetic Variation →
• Quantitative Sensory Testing (QST) — all drugs for Quantitative Sensory Testing (QST) →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 99, any sex, with Genotype or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain are known as "crises." High rates of pain crises are associated with a higher risk of early death. Some people with sickle cell disease have many severe pain crises while others experience fewer crises. This difference in pain crisis may be caused by sensitivity to pain. People with high sensitivity to pain may have more pain crises. Many factors, including a person's genetic makeup, determine sensitivity to pain. Comparing genetic information from people with sickle cell disease and healthy volunteers may provide more information on pain and sickle cell disease.

Objectives:

\- To study genetics and pain sensitivity in sickle cell disease.

Eligibility:

* African or African American individuals at least 18 years of age with sickle cell disease.
* Healthy African or African American volunteers at least 18 years of age.

Design:

* Participants will be screened with a medical history and physical exam. They will also provide blood and urine samples.
* Participants will have the following tests:
* Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and mechanical pain.
* EndoPat test to measure blood vessel function and reaction.
* Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep disturbances.
* Measures of daily pain, whether or not related to sickle cell disease.
* After the first visit, those in the study will have monthly study visits for 6 months. The above tests will be repeated at these visits.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epidermal devices for noninvasive, precise, and continuous mapping of macrovascular and microvascular blood flow.
   Webb RC, Ma Y, Krishnan S, Li Y, et al · · 2015 · cited 99× · PMID 26601309 · DOI 10.1126/sciadv.1500701
2. Pro-inflammatory cytokines associate with NETosis during sickle cell vaso-occlusive crises.
   Barbu EA, Mendelsohn L, Samsel L, Thein SL. · · 2020 · cited 35× · PMID 31778959 · DOI 10.1016/j.cyto.2019.154933
3. Central sensitization associated with low fetal hemoglobin levels in adults with sickle cell anemia.
   Darbari DS, Vaughan KJ, Roskom K, Seamon C, et al · · 2017 · cited 16× · PMID 28969994 · DOI 10.1016/j.sjpain.2017.08.001