Propanolol and Red Cell Adhesion Non-asthmatic Children Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | June 2010 |
| End Date: | December 2017 |
| Contact: | Ofelia Alvarez, MD |
| Email: | oalvarez2@med.miami.edu |
| Phone: | 305.243.0846 |
Propanolol Effect on Red Cell Adhesion in Non-Asthmatic Children With Sickle Cell Disease: A Dose Finding Study
Propanolol is a beta blocker which has been found to inhibit the ability of epinephrine to
upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose
of this pilot study is to administer one dose of propanolol to children with sickle cell
disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single
dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as
compared to baseline.
upregulate sickle red cell adhesion to laminin and endothelial cells in vitro. The purpose
of this pilot study is to administer one dose of propanolol to children with sickle cell
disease and to measure pre and post dose red cell adhesion. The hypothesis is that a single
dose of propanolol will decrease red cell adhesion to laminin and endothelial cells as
compared to baseline.
A similar pilot study has already been conducted in adults and is now being tried in
children to gather preliminary data for a grant submission. No safety issues were found in
the adult pilot study. This study will evaluate the effect of different doses of propanolol.
The risks of this study involve the risks of three (3) blood draws and the risks of
propanolol. In order to minimize the risks children with sickle cell disease and asthma will
be excluded because asthma is a contraindication to the use of propanolol. In addition,
patients will not be hypertensive or bradycardic.
children to gather preliminary data for a grant submission. No safety issues were found in
the adult pilot study. This study will evaluate the effect of different doses of propanolol.
The risks of this study involve the risks of three (3) blood draws and the risks of
propanolol. In order to minimize the risks children with sickle cell disease and asthma will
be excluded because asthma is a contraindication to the use of propanolol. In addition,
patients will not be hypertensive or bradycardic.
Inclusion Criteria:
1. diagnosis of HbSS or HbSBeta0Thal
2. age 7-17 years
3. Weight 30kg or greater
4. Hb 7mg/dL or greater
5. informed consent
Exclusion Criteria:
1. History of vaso-occlusive crisis during the past 6 weeks, or history of transfusion
during the past 3 months.
2. pregnancy
3. history of heart failure, myocardial infarction, asthma, bradyarrythmias,
hypotension, thyroid disease, diabetes, renal insufficiency
4. concurrent medications: any antihypertensive medication, diuretics, thyroid
replacement medications, any arrythmia medication, insulin, hypoglycaemic medication
5. history of allergy to sulfonamides
6. elevated BUN or creatinine
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
Principal Investigator: Ofelia Alvarez, MD
Phone: 305-243-0846
University of Miami A private research university with more than 15,000 students from around the...
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