CoagulopathyNCT05530161
Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy
An observational study of Coagulopathy and Trauma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Coagulopathy, Trauma
- What is being tested?
- hypocalcemia
- How many people
- 371 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Sep 2023
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020
Who may be able to join
- age≥65 years old
- history of trauma
Who cannot join
- previous anticoagulants or antiplatelet medication;
- Coagulopathy caused by previous underlying diseases;
- Blood products transfused before admission;
- Cardiac arrest on admission;
- Malignant tumor;
- Data incomplete
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
SAHZU
Hanzhou, Zhejiang, 310009
Yongan Xu, 13757164833, xuyongan2000@163.com
About this study
Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.
Read the detailed description
This 5-year retrospective, observational, single-center study was conducted at the Second Affiliated Hospital of Zhejiang University Medical School (SAHZU, China). Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020.The purpose of this study is to elucidate the effect of hypocalcemia on TIC in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for TIC in elderly trauma patients.
- Conditions
- Coagulopathy, Trauma
- Being tested
- hypocalcemia
- Keywords
- trauma
- Medical subject headings
- Hemostatic Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypocalcemiaOther
hypocalcemia or normocalcemia
| Study group | Role | What they receive |
|---|---|---|
| trauma induced coagulopathy | patients with INR>1.2 Receives: Other: hypocalcemia | |
| non-trauma induced coagulopathy | patients with INR≤1.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internationalized Normalized Ratio (INR)
coagulation function :Internationalized Normalized Ratio (INR)
Measured: 24 hour
Activated Partial Thromboplastin Time (APTT)
coagulation function : Activated Partial Thromboplastin Time (APTT)
Measured: 24 hour
Prothrombin Time (PT)
coagulation function : Prothrombin Time (PT)
Measured: 24 hour
Secondary outcomes (1)
Blood products rate
the rate of Blood products use
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2015
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulopathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 371 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yongan xu, doctor, Study chair, Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530161
- Sponsor's protocol ID
- 2020-822
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 7 Sep 2022
- 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 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy
- ClinicalTrials.gov ID
- NCT05530161
- Acronym / sponsor ID
- 2020-822
- Conditions
- Coagulopathy, Trauma
- Keywords
- trauma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 371 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 7 Sep 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.
Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.
Detailed description
This 5-year retrospective, observational, single-center study was conducted at the Second Affiliated Hospital of Zhejiang University Medical School (SAHZU, China). Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020.The purpose of this study is to elucidate the effect of hypocalcemia on TIC in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for TIC in elderly trauma patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trauma induced coagulopathy | – | Other: hypocalcemiapatients with INR>1.2 |
| non-trauma induced coagulopathy | – | –patients with INR≤1.2 |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020
Key inclusion criteria (2 listed)
- age≥65 years old
- history of trauma
Key exclusion criteria (6 listed)
- previous anticoagulants or antiplatelet medication;
- Coagulopathy caused by previous underlying diseases;
- Blood products transfused before admission;
- Cardiac arrest on admission;
- Malignant tumor;
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 |
|---|---|---|
| hypocalcemiahypocalcemia or normocalcemia | Other | trauma induced coagulopathy |
Primary outcome
Internationalized Normalized Ratio (INR)
Time frame: 24 hour
coagulation function :Internationalized Normalized Ratio (INR)
Activated Partial Thromboplastin Time (APTT)
Time frame: 24 hour
coagulation function : Activated Partial Thromboplastin Time (APTT)
Prothrombin Time (PT)
Time frame: 24 hour
coagulation function : Prothrombin Time (PT)
1 secondary outcome
Blood products rate
Time frame: through study completion, an average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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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.
yongan xu, doctor study chair
Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang 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 Coagulopathy and Trauma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 6 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 7 Sep 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 yongan xu, doctor (13757164833, xuyongan2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internationalized Normalized Ratio (INR) (time frame: 24 hour). The study lists 3 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 7 Sep 2022.