Spinal FusionNCT05661838
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications
An observational study of Spinal Fusion and Transfusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. Read more about this study
- Who is it for?
- Ages 9 to 82 years
- Conditions the study is for
- Spinal Fusion, Transfusion, Pulmonary Complication
- What is being tested?
- transfusion
- Type of treatment
- Surgery or procedure
- How many people
- 272 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2013to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 82 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients were included if they underwent post vertebral column resection (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020
Who may be able to join
- Patients were included if they underwent elective spine surgery (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020
Who cannot join
- combined anterior-posterior surgery
- growth rod adjustment surgery
- spinal tumor.
- surgery took fewer than 3 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
About this study
Official title: Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications in Elective Spinal Surgery: a Retrospective Cohort Study
Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.
- Conditions
- Spinal Fusion, Transfusion, Pulmonary Complication
- Being tested
- transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transfusionProcedure or surgery
transfusion
| Study group | Role | What they receive |
|---|---|---|
| non-PPCs group | Patients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) Receives: Procedure: transfusion | |
| PPCs group | Patients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) Receives: Procedure: transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between blood transfusion and postoperative pulmonary complications
Correlation between blood transfusion and postoperative pulmonary complications
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Aug 2013
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, doctor, Study chair, The Second Affiliated Hospital of Zhejiang University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661838
- Sponsor's protocol ID
- 2022-0968
- Status last verified
- Aug 2013
- First submitted
- 15 Dec 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications in Elective Spinal Surgery: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05661838
- Acronym / sponsor ID
- 2022-0968
- Conditions
- Spinal Fusion, Transfusion, Pulmonary Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-PPCs group | – | Procedure: transfusionPatients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) |
| PPCs group | – | Procedure: transfusionPatients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection) |
Who may qualify
- Ages
- 9 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients were included if they underwent post vertebral column resection (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020
Key inclusion criteria (1 listed)
- Patients were included if they underwent elective spine surgery (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020
Key exclusion criteria (4 listed)
- combined anterior-posterior surgery
- growth rod adjustment surgery
- spinal tumor.
- surgery took fewer than 3 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transfusiontransfusion | Procedure or surgery | PPCs group, non-PPCs group |
Primary outcome
Correlation between blood transfusion and postoperative pulmonary complications
Time frame: 28 days after surgery
Correlation between blood transfusion and postoperative pulmonary complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Yan, doctor study chair
The Second Affiliated Hospital of Zhejiang University Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Fusion and Transfusion, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between blood transfusion and postoperative pulmonary complications (time frame: 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.