NCT05661838

Brief 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. However, whether it influences risk of other PPCs is unclear.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
Last Updated

December 22, 2022

Status Verified

August 1, 2013

Enrollment Period

7.3 years

First QC Date

December 15, 2022

Last Update Submit

December 21, 2022

Conditions

Spinal FusionTransfusionPulmonary Complication

Outcome Measures

Primary Outcomes (1)

  • Correlation between blood transfusion and postoperative pulmonary complications

    Correlation between blood transfusion and postoperative pulmonary complications

    28 days after surgery

Study Arms (2)

non-PPCs group

Patients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)

Procedure: transfusion

PPCs group

Patients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)

Procedure: transfusion

Interventions

transfusionPROCEDURE

transfusion

PPCs groupnon-PPCs group

Eligibility Criteria

Age9 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • combined anterior-posterior surgery
  • growth rod adjustment surgery
  • spinal tumor.
  • surgery took fewer than 3 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Blood Transfusion

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Min Yan, doctor

    The Second Affiliated Hospital of Zhejiang University Medical College

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2022

First Posted

December 22, 2022

Study Start

August 1, 2013

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

December 22, 2022

Record last verified: 2013-08

Locations

CN(1)