Disseminated Intravascular CoagulationNCT05995093
The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
An observational study of Disseminated Intravascular Coagulation, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation. Read more about this study
- Who is it for?
- Ages 18 to 94 years
- Conditions the study is for
- Disseminated Intravascular Coagulation
- How many people
- 462 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 30 Jun 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 18 to 94 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31 December 2022 were involved in our study.
Who may be able to join
- 18 years old, non-perinatal period, a hospitalization length of≥3 days.
Who cannot join
- primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Miao Xu
Ji'nan, Shandong, 250000
Miao Xu, MD, PhD, 0531-82169885, miao.xu@sdu.edu.cn
About this study
The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.
Read the detailed description
Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.
- Conditions
- Disseminated Intravascular Coagulation
- Being tested
- no intervention
- Keywords
- Thrombosis, Coagulation, Hemostatic Biomarkers, DIC
- Medical subject headings
- Disseminated Intravascular Coagulation, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| non-DIC group | Not described Receives: Other: no intervention | |
| pre-DIC group | Not described Receives: Other: no intervention | |
| overt-DIC group | Not described Receives: Other: no intervention | |
| DIC group | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether DIC occured
DIC includes pre-DIC and overt-DIC
Measured: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.
Secondary outcomes (1)
whether death occurred
Based on the death records in the electronic medical records
Measured: From date of admission until the date of death, assessed up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Dec 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disseminated Intravascular CoagulationStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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-control
- Time perspective
- Retrospective
- Enrolment
- 462 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miao Xu, MD, Qilu Hospital of Shandong University
- Investigators
- Miao Xu, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995093
- Sponsor's protocol ID
- Hemostatic Biomarkers in DIC
- Status last verified
- Oct 2023
- First submitted
- 6 Aug 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Proactive Diagnostic Value of Hemostatic Biomarkers in Disseminated Intravascular Coagulation
- ClinicalTrials.gov ID
- NCT05995093
- Acronym / sponsor ID
- Hemostatic Biomarkers in DIC
- Conditions
- Disseminated Intravascular Coagulation
- Keywords
- Thrombosis, Coagulation, Hemostatic Biomarkers, DIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 462 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Aug 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.
The project was undertaking by Qilu Hospital of Shandong University, aiming to evaluate diagnostic performance of hemostatic biomarkers in disseminated intravascular coagulation.
Detailed description
Disseminated intravascular coagulation (DIC) is a life-threatening condition with high mortality, necessitating timely and accurate diagnosis for effective management. However, current diagnostic systems can not recognize DIC at its reversible phase, causing suboptimal treatment outcomes. Consequently, the current diagnostic criteria for DIC lacks earlier laboratory indicators. Therefore, the investigators aimed to assess the diagnostic potential of selected hemostatic biomarkers, including thrombin-antithrombin complex (TAT), soluble thrombomodulin (sTM), tissue plasminogen activator inhibitor complex (tPAI-C), α2-plasmin inhibitor plasmin complex (PIC) and anti-thrombin III (ATIII), in evaluating DIC, allowing for proactive diagnosis before the disease progresses into its irreversible phase.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| non-DIC group | – | Other: no intervention |
| pre-DIC group | – | Other: no intervention |
| overt-DIC group | – | Other: no intervention |
| DIC group | – | Other: no intervention |
Who may qualify
- Ages
- 18 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients admitted to intensive care unit of Qilu Hospital from 1 January 2021 to 31 December 2022 were involved in our study.
Key inclusion criteria (1 listed)
- 18 years old, non-perinatal period, a hospitalization length of≥3 days.
Key exclusion criteria (1 listed)
- primary hematologic diseases, decompensated liver cirrhosis, chemotherapy history.
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 interventionno intervention | Other | DIC group, non-DIC group, overt-DIC group, pre-DIC group |
Primary outcome
whether DIC occured
Time frame: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.
DIC includes pre-DIC and overt-DIC
1 secondary outcome
whether death occurred
Time frame: From date of admission until the date of death, assessed up to 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Disseminated Intravascular Coagulation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruiting
Safflower (Carthamus Tinctorius L.) Granules for Sepsis-associated Coagulopathy
Sepsis, Disseminated Intravascular Coagulation (DIC)
Active, not recruitingObservational study
An Observational Study in the United States to Learn How Venous Thromboembolism, Disseminated Intravascular Coagulation, and Sepsis Are Related
Sepsis, Venous Thromboembolism
RecruitingPhase 1
A Study to Learn About How Safe BAY 3389934 is, Its Suitable Dose, and How it Affects the Participants With Sepsis Induced Coagulopathy
Sepsis, Coagulopathy
Not yet recruitingObservational study
EARLY DIAGNOSIS OF SEPTIC DIC
Disseminated Intravascular Coagulation (DIC), Reanimation
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.
Miao Xu principal investigator
Qilu 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?
An observational study of Disseminated Intravascular Coagulation, run by Qilu 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 1 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 24 Oct 2023. 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 Miao Xu (0531-82169885, miao.xu@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether DIC occured (time frame: From date of detecting hemostatic biomarkers until the date of first ISTH-DIC scores ≥5, assessed up to 7 days.). 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 Oct 2023.