Blood Coagulation DisorderNCT05698160
Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction
An observational study of Blood Coagulation Disorder, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation Disorder
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 31 Dec 2025
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The critically ill patients treated with tigecycline in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Who may be able to join
- Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Intravenous tigecycline ≥ 3 days
- Monitoring the plasma concentration of tigecycline
Who cannot join
- Missing clinical data
About this study
Official title: Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology
This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline
Read the detailed description
The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.
- Conditions
- Blood Coagulation Disorder
- Keywords
- Tigecycline, Blood Coagulation Disorder, multi-omics, machine learning techbology
- Medical subject headings
- Blood Coagulation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| coagulation dysfunction group | The critically ill patients in intensive care unit showed coagulation dysfunction after treated with tigecycline. | |
| non-coagulation dysfunction group | The critically ill patients in intensive care unit showed normal coagulation function after treated with tigecycline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers associated with the coagulation dysfunction induced tigecycline
Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline.
Measured: January 2023-December 2025
Secondary outcomes (1)
Prediction model for coagulation dysfunction induced by tigecycline
Machine learning techbology will be adopted to establish the prediction model for coagulation dysfunction induced by tigecycline
Measured: January 2023-December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation DisorderStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698160
- Sponsor's protocol ID
- 2022-LCYJ-PY-14
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology
- ClinicalTrials.gov ID
- NCT05698160
- Acronym / sponsor ID
- 2022-LCYJ-PY-14
- Conditions
- Blood Coagulation Disorder
- Keywords
- Tigecycline, Blood Coagulation Disorder, multi-omics, machine learning techbology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Jan 2023 (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 is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline
Detailed description
The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coagulation dysfunction group | – | –The critically ill patients in intensive care unit showed coagulation dysfunction after treated with tigecycline. |
| non-coagulation dysfunction group | – | –The critically ill patients in intensive care unit showed normal coagulation function after treated with tigecycline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The critically ill patients treated with tigecycline in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Key inclusion criteria (3 listed)
- Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Intravenous tigecycline ≥ 3 days
- Monitoring the plasma concentration of tigecycline
Key exclusion criteria (1 listed)
- Missing clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers associated with the coagulation dysfunction induced tigecycline
Time frame: January 2023-December 2025
Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline.
1 secondary outcome
Prediction model for coagulation dysfunction induced by tigecycline
Time frame: January 2023-December 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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 Blood Coagulation Disorder, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
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?
Biomarkers associated with the coagulation dysfunction induced tigecycline (time frame: January 2023-December 2025). 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 19 Apr 2023.