Aspirin SensitivityNCT05511441
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
A study testing Surgery Without Aspirin Withdraw in people with Aspirin Sensitivity and Surgery, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aspirin Sensitivity, Surgery
- What is being tested?
- Surgery Without Aspirin Withdraw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Jun 2025
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;
- VATS and robotic surgery are both permitted;
- cardio-pulmonary function can tolerate surgery.
Who cannot join
- cardio-pulmonary function couldn't tolerate surgery;
- high bleeding risk after the pre- operative evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital Of Shandong Univercity
Jinan, Tianqiao, 250033
Xiaogang Zhao, +8617660080007, zhaoxiaogang@sdu.edu.cn
About this study
Official title: Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery
Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. This single- arm study was to evaluate the safety of continuous use of ASA in the perioperative period in routine minimally thoracic surgery.
- Conditions
- Aspirin Sensitivity, Surgery
- Being tested
- Surgery Without Aspirin Withdraw
- Keywords
- Aspirin, Minimally Invasive Thoracic Surgery, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery Without Aspirin WithdrawProcedure or surgery
Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw
| Study group | Role | What they receive |
|---|---|---|
| Surgery Without Aspirin Withdraw | Experimental | Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Receives: Procedure: Surgery Without Aspirin Withdraw |
What is being measured
The primary outcome is the main question the study is designed to answer.
bleeding volume
bleeding volume during surgery
Measured: on the surgery day
surgery time
total surgery time
Measured: on the surgery day
postoperative drainage volume
chest drainage volume after surgery
Measured: within 7 days after surgery
postoperative drainage duration
chest drainage duration after surgery
Measured: within 7 days after surgery
postoperative hospitalization time
postoperative hospitalization time
Measured: within 7 days after surgery
postoperative complication rate
postoperative complication rate
Measured: within 14 days after surgery
Secondary outcomes (2)
progression- free survival
progression- free survival
Measured: within 5 years after surgery
overall survival
overall survival
Measured: within 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jun 2020
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspirin SensitivityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511441
- Sponsor's protocol ID
- Aspirin ZYP
- Status last verified
- Aug 2022
- First submitted
- 19 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw Before Surgery
- ClinicalTrials.gov ID
- NCT05511441
- Acronym / sponsor ID
- Aspirin ZYP
- Conditions
- Aspirin Sensitivity, Surgery
- Keywords
- Aspirin, Minimally Invasive Thoracic Surgery, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 23 Aug 2022 (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.
Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, the perioperative management of these patients undergo non-cardiac surgery has not yet been clear. This single- arm study was to evaluate the safety of continuous use of ASA in the perioperative period in routine minimally thoracic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery Without Aspirin Withdraw | Experimental | Procedure: Surgery Without Aspirin WithdrawRoutine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with stage I-IIIa Non-small-cell Lung Cancer underwent radical resection or other benign lung lesions need Minimally Invasive Thoracic Surgery;
- VATS and robotic surgery are both permitted;
- cardio-pulmonary function can tolerate surgery.
Key exclusion criteria (2 listed)
- cardio-pulmonary function couldn't tolerate surgery;
- high bleeding risk after the pre- operative evaluation.
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 |
|---|---|---|
| Surgery Without Aspirin WithdrawRoutine Minimally Invasive Thoracic Surgery Without Aspirin Withdraw | Procedure or surgery | Surgery Without Aspirin Withdraw |
Primary outcome
bleeding volume
Time frame: on the surgery day
bleeding volume during surgery
surgery time
Time frame: on the surgery day
total surgery time
postoperative drainage volume
Time frame: within 7 days after surgery
chest drainage volume after surgery
postoperative drainage duration
Time frame: within 7 days after surgery
chest drainage duration after surgery
postoperative hospitalization time
Time frame: within 7 days after surgery
postoperative hospitalization time
postoperative complication rate
Time frame: within 14 days after surgery
postoperative complication rate
2 secondary outcomes
progression- free survival
Time frame: within 5 years after surgery
overall survival
Time frame: within 10 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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.
Xiaogang Zhao study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery Without Aspirin Withdraw in people with Aspirin Sensitivity and Surgery, run by The Second Hospital of Shandong University at 1 site in China.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Zhao (18766188692, zyp_baggio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding volume (time frame: on the surgery day). The study lists 6 primary outcomes in all. 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 23 Aug 2022; AzTrials last refreshed its copy on 4 Nov 2026.