Diurnal Variation of Coagulation FunctionNCT07841613
Exploring the Impact of Diurnal Variation on Coagulation Function in Patients Undering Tumor Surgery
An observational study of Diurnal Variation of Coagulation Function, run by Fudan University at 1 site in China.
Trial summary
Studies have shown that compared to the evening, the platelet adhension and aggregation functions of normal individuals are stronger in the morning, reaching peak at around 8AM or 9AM. Fibrinolysis is weakest at 7-11AM, and most active at midnight. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diurnal Variation of Coagulation Function
- What is being tested?
- No Biologics
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects of the study were 83 patients scheduled for gastrointestinal tumor surgery under general anesthesia.
Who may be able to join
- 1) Patients who signed the informed consent form and were willing to complete the study according to the protocol.
- 2) Patients who underwent surgical treatment for digestive tract tumors. 3) The operation start time was from 8:00 to 9:00 in the morning and from 19:00 to 20:00 in the evening.
- 4) ASA grade I-II. 5) Age ranging from 20 to 70 years old.
Who cannot join
- 1) History of thrombosis-related diseases 2) Use of anticoagulants (excluding aspirin, which should be discontinued for one week) 3) Hb < 90g/dL 4) Diabetic patients [14] 5) Patients admitted to ICU after surgery 10) Those who have participated in other clinical trials or refused to join the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200333
About this study
Studies have shown that compared to the evening, the platelet adhension and aggregation functions of normal individuals are stronger in the morning, reaching peak at around 8AM or 9AM. Fibrinolysis is weakest at 7-11AM, and most active at midnight. previous studies have been contradictory regarding the rhythm of plasmin. Some show the level of plasmin complexes is highest at night, while some show higher in the morning and some show there is no rhythmicity.
Since patients with tumors often have a hypercoagulable state, we try to find a method to assess whether cancer patients have the same circadian with heathy individuals. And whether the surgery time(in the morning or in the evening) will affect the tumor patients' postoperative coagulation function
- Being tested
- No Biologics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No BiologicsOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| morning surgery group | Not described | |
| night surgery group | Not described Receives: Other: No Biologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative TEG values
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Jun 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diurnal Variation of Coagulation FunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841613
- Sponsor's protocol ID
- FudanU25.4.21
- Status last verified
- May 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Diurnal Variation on Coagulation Function in Patients Undering Tumor Surgery
- ClinicalTrials.gov ID
- NCT07841613
- Acronym / sponsor ID
- FudanU25.4.21
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 25 Sep 2026 (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.
Studies have shown that compared to the evening, the platelet adhension and aggregation functions of normal individuals are stronger in the morning, reaching peak at around 8AM or 9AM. Fibrinolysis is weakest at 7-11AM, and most active at midnight. previous studies have been contradictory regarding the rhythm of plasmin. Some show the level of plasmin complexes is highest at night, while some show higher in the morning and some show there is no rhythmicity.
Since patients with tumors often have a hypercoagulable state, we try to find a method to assess whether cancer patients have the same circadian with heathy individuals. And whether the surgery time(in the morning or in the evening) will affect the tumor patients' postoperative coagulation function
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning surgery group | – | – |
| night surgery group | – | Other: No Biologics |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects of the study were 83 patients scheduled for gastrointestinal tumor surgery under general anesthesia.
Key inclusion criteria (3 listed)
- 1) Patients who signed the informed consent form and were willing to complete the study according to the protocol.
- 2) Patients who underwent surgical treatment for digestive tract tumors. 3) The operation start time was from 8:00 to 9:00 in the morning and from 19:00 to 20:00 in the evening.
- 4) ASA grade I-II. 5) Age ranging from 20 to 70 years old.
Key exclusion criteria (1 listed)
- 1) History of thrombosis-related diseases 2) Use of anticoagulants (excluding aspirin, which should be discontinued for one week) 3) Hb < 90g/dL 4) Diabetic patients [14] 5) Patients admitted to ICU after surgery 10) Those who have participated in other clinical trials or refused to join the study.
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 |
|---|---|---|
| No Biologicsno intervention | Other | night surgery group |
Primary outcome
preoperative TEG values
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diurnal Variation of Coagulation Function, run by Fudan 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 1 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: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
preoperative TEG values (time frame: one day). 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 25 Sep 2026.