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
A randomized parallel trial on effects of different hemostatic sponges in posterior spinal fusion surgeries
The aim of this study is to assess the impact of three different hemostatic materials on operative blood loss in spinal fusion surgery.
Peking Union Medical College Hospital Ethics Committee, 11/06/2014, ref: HS2014046
Three-arm randomised parallel trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
No participant information sheet available
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.
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
Overall trial end date
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Peking Union Medical College Hospital
No.1 Shuai Fu Yuan, Wang Fu Jing Street, Beijing, China.
Peking Union Medical College Hospital
Department of Orthorpaedic Surgery
No.1 Shuai Fu Yuan
Wang Fu Jing Street
Wuxi Biot Bio-technology co. Ltd
Funding Body Type
Funding Body Subtype
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 (email@example.com)
Intention to publish date
Participant level data
Available on request
Results - basic reporting
See additional file ISRCTN29254316_BasicResults_15Oct2016
- ISRCTN29254316_BasicResults_15Oct2016.docx Uploaded 26/10/2016