Acetylcysteine in Patients With Sickle Cell Disease (NAC).
Recruiting
- Conditions
- Sickle Cell DiseaseSickle Cell AnemiaPainful CrisisPainSikkelcel ziekteSikkelcel anemiePijnlijke crisePijn
- Registration Number
- NL-OMON28196
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Inclusion Criteria
1. Age 12 years or older;
2. Sickle cell disease, either homozygous sickle cell disease (HbSS), compound heterozygous sickle cell disease (HbSC), HbSβ0 or HbSβ+ thalassemia;
Exclusion Criteria
1. Chronic blood transfusion or transfusion in the preceding 3 months;
2. Painful crisis in the last 4 weeks (with respect to the moment of inclusion);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency of SCD related pain in daily life in patients with Sickle Cell Disease evaluated over a period of 6 months.
- Secondary Outcome Measures
Name Time Method 1. The severity of SCD related pain in daily life;<br /><br>2. The incidence and severity of painful crises;<br /><br>3. The frequency and length of hospital admissions;<br /><br>4. The health-related Quality of Life;<br /><br>5. The SCD-related societal costs;<br /><br>6. The tolerability of NAC;<br /><br>7. Frequency of use of pain medication at home;<br /><br>8. Frequency of SCD complications (e.g. acute chest syndrome);<br /><br>9. The changes in hematological markers of oxidative stress, hemolysis, hypercoagulability, inflammation, erythrocyte adhesion and endothelial dysfunction.