Condition category
Surgery
Date applied
14/10/2016
Date assigned
25/10/2016
Last edited
26/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Lumbar stenosis is a condition where there is a narrowing of the spinal canal (space in the spine that the spinal cord travels through) in the lower back. This narrowing puts pressure on the nerves that make up the spinal cord leading to pain in the legs. In some patients, the pain can be so severe that it can prevent them from walking and surgery is the main treatment option. Patients undergoing surgery on the spine are at risk of losing large quantities of blood during the surgery. This may lead to the need for blood transfusions after surgery which can extend their stay in hospital. Stablising blood flow during surgery is an important way of controlling blood loss and being able to perform the surgery well. In recent years, use of certain types of sponges have been a good way for controlling blood loss, however it is not known which is the most effective. The aim of this study is to compare the effectiveness of three different haemostatic (blood controlling) sponges on blood loss in spinal surgery patients.

Who can participate?
Patients with spinal stenosis who are suitable for spinal surgery.

What does the study involve?
Participants are randomly allocated to one of three groups. All patients are treated using standard surgical techniques and have their bleeding controlled by having the blood vessels that have been cut during surgery sealed off. They then have a sponge placed on the area which is either made from gelatin, or one of two types of cellulose (a plant material). Participants in all groups are then followed up for 48 hours after surgery to monitor blood loss.

What are the possible benefits and risks of participating?
Participants in all groups should benefit from lower levels of bleeding after surgery. There are no direct risks involved with participating.

Where is the study run from?
Peking Union Medical College Hospital (China)

When is the study starting and how long is it expected to run for?
November 2013 to December 2016

Who is funding the study?
Wuxi Biot Bio-technology co. Ltd (China)

Who is the main contact?
Mr Shugang Li

Trial website

Contact information

Type

Public

Primary contact

Mr Shugang Li

ORCID ID

Contact details

Department of Orthorpaedic Surgery
Peking Union Medical College Hospital
No.1 Shuai Fu Yuan
Wang Fu Jing Street
BeiJing
100170
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomized parallel trial on effects of different hemostatic sponges in posterior spinal fusion surgeries

Acronym

Study hypothesis

The aim of this study is to assess the impact of three different hemostatic materials on operative blood loss in spinal fusion surgery.

Ethics approval

Peking Union Medical College Hospital Ethics Committee, 11/06/2014, ref: HS2014046

Study design

Three-arm randomised parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Spinal surgery

Intervention

Participants are randomly allocated to one of three groups using a simple equal probability randomization scheme. All participants undergo posterior lumbar decompression, internal fixation or bone graft fusion surgery by the same surgeon using standard techniques.

Group A: Following decompression post-operative bleeding is controlled using bipolar electrocautery, after which a Stypro hemostatic sponge is placed on the surface of the spinal dura mater.
Group B: Following decompression post-operative bleeding is controlled using bipolar electrocautery, after which a Collagen hemostatic sponge is placed on the surface of the spinal dura mater.
Group C: Following decompression post-operative bleeding is controlled using bipolar electrocautery, after which a Gelatin sponge is placed on the surface of the spinal dura mater.

Participants are followed up for 48 hours after surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Postoperative drainage is measured using a measuring cylinder over the first 24 hours after surgery, the second 24 hours after surgery.

Secondary outcome measures

Intraoperative estimated blood loss (EBL) is calculated on the basis of surgical sponges soaked and volume in suction canisters, subtracting irrigation fluid added to the surgical field immediately after surgery.

Overall trial start date

01/11/2013

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Lumbar stenosis
2. Disc disease
3. Instability (e.g. grade I-II spondylolisthesis, spondylolisthesis /spondylolysis)
4. Indicated for spinal surgeries
5. Aged 50 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Severe medical comorbidities such as osteoporosis, anemia and cardiovascular disease
2. Involvement of more than three surgical levels
3. Patients had abnormal prothrombin time (PT), partial thromboplastin time (PTT) and International Normalized Ratio (INR)
4. Patients were taking anti-platelet aggregates such as Aspirin or other anticoagulants

Recruitment start date

30/06/2014

Recruitment end date

01/03/2015

Locations

Countries of recruitment

China

Trial participating centre

Peking Union Medical College Hospital
No.1 Shuai Fu Yuan, Wang Fu Jing Street, Beijing, China.
Beijing
100170
China

Sponsor information

Organisation

Peking Union Medical College Hospital

Sponsor details

Department of Orthorpaedic Surgery
No.1 Shuai Fu Yuan
Wang Fu Jing Street
Beijing
100730
China

Sponsor type

Hospital/treatment centre

Website

http://www.pumch.cn/Index.html

Funders

Funder type

Industry

Funder name

Wuxi Biot Bio-technology co. Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Derong Xu (xuderong19880001@163.com)

Intention to publish date

01/12/2017

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN29254316_BasicResults_15Oct2016

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: The basic results summary file has been uploaded.