Effect of Intraoperative Allogeneic Blood Transfusion on... | NCT05661838

Studies
Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications

NCT05661838

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Dec 22, 2022Actual

Enrollment

272Actual

Phase

Not provided

Conditions

Spinal Fusion
Transfusion
Pulmonary Complication

Interventions

transfusion

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2013Actual

Primary Completion Date

Oct 31, 2020Actual

Completion Date

Oct 31, 2020Actual

First Submitted Date

Dec 15, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Dec 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2022

Last Update Posted Date

Dec 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

272Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
transfusion	Procedure	transfusion	PPCs group non-PPCs group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between blood transfusion and postoperative pulmonary complications	Correlation between blood transfusion and postoperative pulmonary complications	28 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

82 Years

Standard Ages

ChildAdultOlder 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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Min Yan, doctor	The Second Affiliated Hospital of Zhejiang University Medical College	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University anesthesiology department		Hangzhou	Zhejiang	310000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001803	Blood Transfusion

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided