Thoracic SurgeryNCT07100509
Major Vascular Injuries in Elective Thoracic Surgery: A 10-Year Single-Center Experience
An observational study of Thoracic Surgery and Vascular Injury, run by Caner İşevi, MD.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thoracic Surgery, Vascular Injury, Intraoperative Complications
- What is being tested?
- Major Vascular Injury During Elective Thoracic Surgery
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: Major Vascular Injuries in Elective Thoracic Surgery: A Single-Center 10-Year Experience
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.
- Being tested
- Major Vascular Injury During Elective Thoracic Surgery
- Keywords
- Elective Thoracic Surgery, Intraoperative Bleeding, Cardiovascular Surgery, Vascular Injury
- Medical subject headings
- Vascular System Injuries, Intraoperative Complications, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Vascular Injury During Elective Thoracic SurgeryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Major Vascular Injury During Elective Thoracic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: During Surgery (Intraoperative Period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2015
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caner İşevi, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Caner İşevi, MD, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100509
- Sponsor's protocol ID
- B.30.2.ODM.0.20.08/ 481
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Vascular Injuries in Elective Thoracic Surgery: A Single-Center 10-Year Experience
- ClinicalTrials.gov ID
- NCT07100509
- Acronym / sponsor ID
- B.30.2.ODM.0.20.08/ 481
- Keywords
- Elective Thoracic Surgery, Intraoperative Bleeding, Cardiovascular Surgery, Vascular Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Caner İşevi, MDUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Intraoperative Vascular Injury | – | Other: Major Vascular Injury During Elective Thoracic SurgeryThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Major Vascular Injury During Elective Thoracic SurgeryThis 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. | Other | Patients With Intraoperative Vascular Injury |
Primary outcome
Incidence of Major Intraoperative Vascular Injuries During Elective Thoracic Surgeries
Time frame: During Surgery (Intraoperative Period)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes
Related trials for Thoracic Surgery
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8
RecruitingPhase 3
A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.
Non Small Cell Lung Cancer
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Surgery and Vascular Injury, run by Caner İşevi, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Intraoperative Vascular Injuries During Elective Thoracic Surgeries (time frame: During Surgery (Intraoperative Period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.