Trauma Patients Received Blood Transfusion ≥ 10 UNCT03786705
Delta Shock Index in Predicting Massive Transfusion
An observational study of Trauma Patients Received Blood Transfusion ≥ 10 U and Trauma Patients Had Not Received Blood Transfusion ≥ 10 U, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: To determine the performance of delta shock index (ΔSI), a change in shock index (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need for massive transfusion (MT) among adult trauma patients with stable blood pressure. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Trauma Patients Received Blood Transfusion ≥ 10 U, Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
- What is being tested?
- Massive transfusion and Non-Massive Transfusion
- How many people
- 7,957 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jun 2018to 20 Dec 2018
- 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 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All hospitalized trauma patients aged 20 years and above from January 1, 2009 to December 31, 2016 from the registered trauma database of the hospital.
Who may be able to join
- Patients who were transferred by emergency medical service (EMS) from the field of accident and had a stable blood pressure (SBP ≥ 90 mmHg) at the ER were included
Who cannot join
- Patients who were transferred from other hospitals or arrived by private vehicles.
- Patients who had incomplete data
- Patients who had an unstable blood pressure (SBP < 90 mmHg) upon arrival at the ER were also excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients
Background: To determine the performance of delta shock index (ΔSI), a change in shock index (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need for massive transfusion (MT) among adult trauma patients with stable blood pressure.
Methods: This study included data from all trauma patients aged 20 years and above who were hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered trauma database of the hospital. Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n = 7,875). The odds ratios with 95% confidence intervals for associated patient conditions and the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the patient's probability of receiving MT.
- Conditions
- Trauma Patients Received Blood Transfusion ≥ 10 U, Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
- Being tested
- Massive transfusion, Non-Massive Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massive transfusionOther
Trauma patients who had received blood transfusion≥10 U
Non-Massive TransfusionOther
Trauma patients who had received blood transfusion<10 U
| Study group | Role | What they receive |
|---|---|---|
| Trauma patients' SBP ≥ 90 mm Hg with EMS | Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The enrolled trauma patients divided into 2 groups, those who had received blood transfusion ≥ 10 U (massive transfusion) and those who had not (non-massive transfusion). Receives: Other: Massive transfusion; Other: Non-Massive Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
To measure the outcome of patients.
Measured: 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 posted26 Dec 2018
- Study start5 Jun 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma Patients Received Blood Transfusion ≥ 10 UStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 7,957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786705
- Sponsor's protocol ID
- CMRPG8G1301
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 26 Dec 2018
- 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 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients
- ClinicalTrials.gov ID
- NCT03786705
- Acronym / sponsor ID
- CMRPG8G1301
- Conditions
- Trauma Patients Received Blood Transfusion ≥ 10 U, Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,957 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 26 Dec 2018 (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.
Background: To determine the performance of delta shock index (ΔSI), a change in shock index (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need for massive transfusion (MT) among adult trauma patients with stable blood pressure.
Methods: This study included data from all trauma patients aged 20 years and above who were hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered trauma database of the hospital. Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n = 7,875). The odds ratios with 95% confidence intervals for associated patient conditions and the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the patient's probability of receiving MT.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma patients' SBP ≥ 90 mm Hg with EMS | – | Other: Massive transfusion, Other: Non-Massive TransfusionOnly patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The enrolled trauma patients divided into 2 groups, those who had received blood transfusion ≥ 10 U (massive transfusion) and those who had not (non-massive transfusion). |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All hospitalized trauma patients aged 20 years and above from January 1, 2009 to December 31, 2016 from the registered trauma database of the hospital.
Key inclusion criteria (1 listed)
- Patients who were transferred by emergency medical service (EMS) from the field of accident and had a stable blood pressure (SBP ≥ 90 mmHg) at the ER were included
Key exclusion criteria (3 listed)
- Patients who were transferred from other hospitals or arrived by private vehicles.
- Patients who had incomplete data
- Patients who had an unstable blood pressure (SBP < 90 mmHg) upon arrival at the ER were also excluded
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 |
|---|---|---|
| Massive transfusionTrauma patients who had received blood transfusion≥10 U | Other | Trauma patients' SBP ≥ 90 mm Hg with EMS |
| Non-Massive TransfusionTrauma patients who had received blood transfusion<10 U | Other | Trauma patients' SBP ≥ 90 mm Hg with EMS |
Primary outcome
in-hospital mortality
Time frame: up to 5 months
To measure the outcome of patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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.
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 Trauma Patients Received Blood Transfusion ≥ 10 U and Trauma Patients Had Not Received Blood Transfusion ≥ 10 U, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 26 Dec 2018. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
in-hospital mortality (time frame: up to 5 months). 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 26 Dec 2018.