Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT05661838

Collaborator

(none)

272

Enrollment

Location

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Fusion Transfusion Pulmonary Complication	Procedure: transfusion

Study Design

Study Type:

Observational

Actual Enrollment :

272 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications in Elective Spinal Surgery: a Retrospective Cohort Study

Actual Study Start Date :

Aug 1, 2013

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
non-PPCs group Patients without PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)	Procedure: transfusion transfusion
PPCs group Patients with PPCs (Pleural effusion, Pulmonary atelectasis, Pulmonary infection)	Procedure: transfusion transfusion

Arm

Intervention/Treatment

non-PPCs group

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

Procedure: transfusion

transfusion

PPCs group

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

Procedure: transfusion

transfusion

Outcome Measures

Primary Outcome Measures

Correlation between blood transfusion and postoperative pulmonary complications [28 days after surgery]
Correlation between blood transfusion and postoperative pulmonary complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Study Chair: Min Yan, doctor, The Second Affiliated Hospital of Zhejiang University Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05661838

Other Study ID Numbers:

2022-0968

First Posted:

Dec 22, 2022

Last Update Posted:

Dec 22, 2022

Last Verified:

Aug 1, 2013

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 22, 2022