Plain English Summary
Background and study aims
Amyotrophic lateral sclerosis (ALS) is a kind of progressive degenerative disease the deteroriates the spinal cord, brain stem and cortical motor neurons (the neurons from the brain). The average survival time from onset to death is 3-5 years. The average age of onset of ALS patients is about 55 years. It has the tendency of being inherited through families in about 5-20% of patients. The disease is not fully understood and there is no effective way to stop the progression of the disease. Plasma adsorption is a new blood purification technology widely used in the treatment of rheumatic diseases (those that affect joints and muscles) and some neurological diseases (diseases that attack the brain and connecting neurons), including myasthenia gravis (muscle weakness that comes and goes), multiple sclerosis and so on. The purpose of this study is to observe the efficacy of PA in the treatment of ALS and to explore its therapeutic mechanism.
Who can participate?
Patients with ALS .
What does the study involve?
Participants received plasma adsorption once a week for three successive times. One and a half times of the plasma volume of a patient is purified for each treatment. Participants are given medication to
prevent anaphylaxis before treatment. Participants are followed up one week after treatment to see if there are any changes in their ALS symptoms.
What are the possible benefits and risks of participating?
Participants may benefit from the improvement of ALS due to plasma adsorption. There are potential risks of allergy, hemorrhage, circulatory disturbance and hemolysis during plasma adsorption. As this procedure have been maturely applied in clinical practice, risks can be controlled very low.
Where is the study run from?
The Third Affiliated Hospital of Southern Medical University (China)
When is the study starting and how long is it expected to run for?
August 2015 to December 2017
Who is funding the study?
Investigator initiated and funded (China)
Who is the main contact?
Dr. Zhou Shulu
1693494745@qq.com
Trial website
Contact information
Type
Public
Primary contact
Dr Shulu Zhou
ORCID ID
http://orcid.org/0000-0001-7870-6175
Contact details
Department of Nephrology
Chengdu First People's Hospital
Sichuan
Chengdu
610041
China
+86 13926227269
1693494745@qq.com
Type
Public
Additional contact
Dr Bin Li
ORCID ID
Contact details
Institute of Nephrology and Urology
The Third Affiliated Hospital of Southern Medical University
Guangdong
PR China
Guangzhou
510630
China
+86 13660196991
250001820@qq.com
Type
Public
Additional contact
Dr Hequn Zou
ORCID ID
Contact details
Institute of Nephrology and Urology
The Third Affiliated Hospital of Southern Medical University
Guangdong
Guangzhou
510630
China
+86 13602825868
hequnzou@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZSL201611
Study information
Scientific title
A Short-term Outcome of Plasma Adsorption Therapy of Amyotrophic Lateral Sclerosis
Acronym
Study hypothesis
Plasma adsorption method can improve ALS patients' clinical manifestations, ALSFR-S scores and level of serum superoxide dismutase, serum interleinin, serum creatine kinase and serum lactate dehydrogenase with comparison to before treatment.
Ethics approval
Medical Ethics Committee The Third Affiliated Hospital of Southern Medical University China, 29/08/2015, ref: 201508004
Study design
Single-center one-arm before-and-after study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Amyotrophic Lateral Sclerosis
Intervention
All patients received plasma adsorption once a week for three successive times. For each treatment, blood flow was 80-120mL/min and the slurry velocity was 1.5 L/h. One and a half times of the Plasma volume of a patient was purified for each treatment. 20 mg dexamethasone and 25 mg phenergan were used to prevent anaphylaxis before treatment.
Each participant was planned to be followed up for two years.
The following results of the treatment are evaluated:
1. Changes of clinical manifestations of ALS patients one week after treatment
2. Change of ALSFR-S scores after treatment
3. Changes of serum superoxide dismutase (SOD), serum interleukin -10 (IL-10), serum creatine kinase (CK) and serum lactate dehydrogenase (LDH) after treatment
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Clinical manifestations of ALS patients is measured using the physical examination at one week after treatment
2. Function evaluation is measured using ALSFR-S scores at one week after treatment
3. Serum creatine kinase (CK) and serum lactate dehydrogenase (LDH) at one week after treatment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/08/2015
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Upper and lower motor neuron signs in three regions
2. Any age or gender
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. Allergic to membranes or pipelines of plasma separator and adsorber
2. Severe active bleeding or DIC; Systemic circulatory failure which do not respond well to treatment
3. Unstable myocardial or cerebral infarction, intracranial hemorrhage or severe brain edema with cerebral hernia
4. Incoordination due to psychonosema
Recruitment start date
01/09/2015
Recruitment end date
31/12/2015
Locations
Countries of recruitment
China
Trial participating centre
The Third Affiliated Hospital of Southern Medical University
510000
China
Sponsor information
Organisation
The Third Affiliated Hospital of Southern Medical University
Sponsor details
TheThird Affiliated Hospital of Southern Medical University
Institute of Nephrology and Urology
No.183 Zhongshan Avenue West
Tianhe District
Guangdong
Guangzhou
-
China
+86 020 62784240
1693494745@qq.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We will publish this study in a high-impact target SCINC by one year after our overall trial end date.
IPD sharing statement:
The datasets generated during and / or analysed during the current study is not expected to be made available due to protecting private information of participants.
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list