NCT07100509

Brief Summary

This study retrospectively examines major vascular injuries that occurred during elective thoracic surgeries over a 10-year period at a single tertiary care center. Although these injuries are rare, they can lead to life-threatening complications. The study aims to determine how often these injuries happen, what causes them, and how they are managed during surgery. It also evaluates the role of preoperative imaging and planning, including cardiovascular surgery team involvement, in preventing or managing these events. The findings are intended to help improve surgical safety and guide future preventive strategies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

10 years

First QC Date

July 27, 2025

Last Update Submit

July 27, 2025

Conditions

Keywords

Elective Thoracic SurgeryIntraoperative BleedingCardiovascular SurgeryVascular Injury

Outcome Measures

Primary Outcomes (1)

  • Incidence of Major Intraoperative Vascular Injuries During Elective Thoracic Surgeries

    The primary outcome is the incidence rate of major vascular injuries identified during elective thoracic surgeries performed between January 2015 and December 2024. Major vascular injury is defined as intraoperative bleeding from central vessels such as the subclavian artery or vein, brachiocephalic vein, innominate artery or vein, superior vena cava (SVC), or thoracic aorta, requiring immediate surgical intervention (e.g., primary repair, grafting, or ligation).

    During Surgery (Intraoperative Period)

Study Arms (1)

Patients With Intraoperative Vascular Injury

This cohort includes patients who experienced major intraoperative vascular injuries during elective thoracic surgeries between January 2015 and December 2024. All patients underwent surgical repair of the injured vessel, such as primary suturing, graft interposition, or ligation. No randomization or intervention assignment was performed. Data were collected retrospectively from medical records to evaluate patient characteristics, surgical details, transfusion requirements, preoperative imaging findings, complication rates, and clinical outcomes. No biospecimens were collected or retained.

Other: Major Vascular Injury During Elective Thoracic Surgery

Interventions

This exposure refers to patients who experienced major vascular injuries during elective thoracic surgery. Injuries involved central vessels such as the subclavian artery, brachiocephalic vein, superior vena cava, and innominate vein. No experimental intervention was applied. The study retrospectively evaluated the surgical management, transfusion requirements, preoperative planning, and clinical outcomes associated with these intraoperative events.

Patients With Intraoperative Vascular Injury

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes adult patients who underwent elective thoracic surgical procedures between January 2015 and December 2024 at a single tertiary care academic center. The study population is limited to patients who experienced major intraoperative vascular injuries involving central thoracic vessels such as the subclavian artery or vein, brachiocephalic vein, innominate artery or vein, superior vena cava (SVC), or thoracic aorta. All included patients required immediate surgical intervention for bleeding control. The study is retrospective and descriptive in nature.

You may qualify if:

  • Patients who underwent elective thoracic surgery between January 2015 and December 2024
  • Development of a major intraoperative vascular injury during surgery
  • Injury involving central vessels such as the subclavian artery or vein, brachiocephalic vein, innominate artery or vein, superior vena cava (SVC), or thoracic aorta
  • Availability of complete operative and postoperative medical records
  • Underwent surgical repair of the vascular injury (e.g., grafting, primary repair, ligation)

You may not qualify if:

  • Patients undergoing emergency thoracic surgery
  • Injuries limited to pulmonary artery or its branches
  • Minor bleeding from peripheral vessels that did not require major intervention
  • Postoperative vascular complications (e.g., delayed hemorrhage, pseudoaneurysm)
  • Missing or incomplete operative records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular System InjuriesIntraoperative ComplicationsBlood Loss, Surgical

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and SymptomsHemorrhage

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 27, 2025

First Posted

August 3, 2025

Study Start

January 1, 2015

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share