Condition category
Musculoskeletal Diseases
Date applied
31/08/2017
Date assigned
20/09/2017
Last edited
22/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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 measures

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

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

http: //www.nysy.com.cn/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/09/2017: Internal review