Effect of plasma adsorption therapy in amyotrophic lateral sclerosis

ISRCTN	ISRCTN22850763
DOI	https://doi.org/10.1186/ISRCTN22850763
Secondary identifying numbers	ZSL201611

Submission date: 31/08/2017
Registration date: 20/09/2017
Last edited: 22/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Shulu Zhou
Public

Department of Nephrology
Chengdu First People's Hospital
Sichuan
Chengdu
610041
China

ORCID ID	0000-0001-7870-6175
Phone	+86 13926227269
Email	1693494745@qq.com

Dr Bin Li
Public

Institute of Nephrology and Urology
The Third Affiliated Hospital of Southern Medical University
Guangdong
PR China
Guangzhou
510630
China

Phone	+86 13660196991
Email	250001820@qq.com

Dr Hequn Zou
Public

Institute of Nephrology and Urology
The Third Affiliated Hospital of Southern Medical University
Guangdong
Guangzhou
510630
China

Phone	+86 13602825868
Email	hequnzou@hotmail.com

Study information

Study design	Single-center one-arm before-and-after study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	A Short-term Outcome of Plasma Adsorption Therapy of Amyotrophic Lateral Sclerosis
Study objectives	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(s)	Medical Ethics Committee The Third Affiliated Hospital of Southern Medical University China, 29/08/2015, ref: 201508004
Health condition(s) or problem(s) studied	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
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 study start date	01/08/2015
Completion date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	28
Key inclusion criteria	1. Upper and lower motor neuron signs in three regions 2. Any age or gender
Key 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
Date of first enrolment	01/09/2015
Date of final enrolment	31/12/2015

Locations

Countries of recruitment

China

Study participating centre

The Third Affiliated Hospital of Southern Medical University

510000
China

Sponsor information

The Third Affiliated Hospital of Southern Medical University
Hospital/treatment centre

TheThird Affiliated Hospital of Southern Medical University
Institute of Nephrology and Urology
No.183 Zhongshan Avenue West
Tianhe District
Guangdong
Guangzhou
-
China

Phone	+86 020 62784240
Email	1693494745@qq.com
Website	http: //www.nysy.com.cn/
"ROR"	https://ror.org/0050r1b65

Funders

Funder type

Not defined

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
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 plan	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.

Editorial Notes

22/09/2017: Internal review