Condition category
Haematological Disorders
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
08/09/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr B.J. Biemond

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 7391
b.j.biemond@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR1013

Study information

Scientific title

Acronym

NAC in SCD

Study hypothesis

We hypothesise that treatment of sickle cell patients with N-acetylcysteine (NAC) results in reduced red cell phosphatidylserine (PS) exposure, reduced endothelial activation, increased nitric oxide (NO) availability, reduced coagulation activation and reduced inflammation detectable with specific laboratory testing, as well as a reduction of irreversibly sickled cells (ISC's) and Heinz Body formation.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Sickle cell disease

Intervention

N-acetylcysteine 1200 mg or 2400 mg a day.

Intervention type

Drug

Phase

Not Specified

Drug names

N-acetylcysteine

Primary outcome measures

Primary end-points are the effects of NAC on the laboratory markers (haemoglobin, red blood cell counts, reticulocyte counts, leukocyte counts and differentiation, platelet counts, erythrocyte sedimentation rate, a blood smear will be analysed microscopically for the number of ISC per field, as well as the number of Heinz bodies, intra-erythrocytic reduced glutathione [GSH] and oxidised glutathione [GSSG] levels, NO availability, SRBC phosphatidylserine [PS] exposure, annexin V, creatinine, blood-urea nitrogen [BUN], electrolytes, transaminase levels, albumin levels, lactate dehydrogenase [LDH], indirect bilirubin levels, free haemoglobin levels, high sensitive C-reactive protein [hsCRP], vascular cell adhesion molecule-1 [sVCAM-1], endothelin [ET-1], interleukin-8 [IL-8], pro-thrombin fragments [F1.2], D-dimer levels, protein S [free and total] and C activity, Von Willebrand factor antigen [vWF-Ag] activity).

Secondary outcome measures

Tolerability of study medication (in this phase admittedly in a non-controlled fashion) at every visit by history taking and by scoring of a NAC for SCD check-list.

Overall trial start date

01/10/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. High performance liquid chromatography confirmed diagnosis of sickle cell anaemia (HbSS), sickle-haemoglobin C disease (HbSC) or sickle cell trait disease (HbSa) genotype
2. Aged 18 to 65 years
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

10

Participant exclusion criteria

1. Blood transfusion in the preceding four months
2. Pregnancy or the desire to get pregnant in the following seven months
3. Concomitant use of hydroxyurea, vitamin K antagonists or other oral anticoagulants, or contraindications for NAC
4. Impaired renal function of more than 60% (as assessed by the Kockroft-Gauld equation)
5. Known gastric or duodenal ulcer
6. Concomitant use of anti-hypertensives, sildefanil or nitrates

Recruitment start date

01/10/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

CURAMA Study Group (The Netherlands)

Sponsor details

c/o Dr B.J. Biemond
Academic Medical Centre (AMC)
Department of Clinical Chemistry
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

CURAMA Study Group (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes