- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05661838
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications
December 21, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
272
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- combined anterior-posterior surgery
- growth rod adjustment surgery
- spinal tumor.
- surgery took fewer than 3 hours.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
non-PPCs group
Patients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)
|
transfusion
|
|
PPCs group
Patients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)
|
transfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between blood transfusion and postoperative pulmonary complications
Time Frame: 28 days after surgery
|
Correlation between blood transfusion and postoperative pulmonary complications
|
28 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Min Yan, doctor, The Second Affiliated Hospital of Zhejiang University Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2013
Primary Completion (Actual)
October 31, 2020
Study Completion (Actual)
October 31, 2020
Study Registration Dates
First Submitted
December 15, 2022
First Submitted That Met QC Criteria
December 21, 2022
First Posted (Estimate)
December 22, 2022
Study Record Updates
Last Update Posted (Estimate)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
August 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 2022-0968
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.