A randomised double blind controlled trial of oral ephedrine/etilefrine in the prevention of recurrent (stuttering) attacks of priapism in sickle cell disease: a multicentre international study in older children and adults

Completed

Conditions: Sickle cell disease
Haematological Disorders
Sickle-cell disorders

Registration Number: ISRCTN54312363

Lead Sponsor: Aintree University Hospitals NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 320

Inclusion Criteria

1. Male patients with a documented history of sickle cell disease (SCD) irrespective of genotype (alpha thalassemia status will not be determined)
2. Patients should be 12 years or over
3. Patients with a known history of stuttering priapism (a short self limiting episode lasting up to 4 hours which tends to be recurrent) attributable to SCD
4. Patients in active attendance at a designated care centre i.e. one visit in the last six months
5. Patients on a stable dose of hydroxyurea for over six months before trial entry, provided a baseline event rate (on treatment) is established before randomisation and no dose change occurs during trial period
6. Patients who received a one-off or isolated top up transfusion greater than three months before recruitment date can be entered into study

Exclusion Criteria

1. Patients with sickle cell trait (haemoglobin A greater than haemoglobin S on alkaline gel electrophoresis or high performance liquid chromatography (HPLC) will not be eligible for randomisation
2. Patients known to have elevated blood pressure or a history of cardiac disease
3. Patients with SCD and a documented history of stroke in the past
4. Patients with a history of acquired vessel aneurysm in the past
5. Patients known to be on MAOI (monoamine oxidase inhibitor) drugs or other drugs with significant interactions with study drugs
6. Patients known to be intolerant of adrenergic drugs
7. Patients with hyperthyroidism
8. Patients on a long-term blood transfusion programme to prevent or treat the complications of SCD

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. A change in the frequency of attacks of stuttering priapism from baseline data<br>2. A change in the incidence of an acute (major) attacks of priapism

Secondary Outcome Measures