Delta Shock Index in Predicting Massive Transfusion

NCT ID: NCT03786705

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-05

Study Completion Date

2018-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Patients Received Blood Transfusion ≥ 10 U Trauma Patients Had Not Received Blood Transfusion ≥ 10 U

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Massive transfusion

Intervention Type OTHER

Trauma patients who had received blood transfusion≥10 U

Non-Massive Transfusion

Intervention Type OTHER

Trauma patients who had received blood transfusion\<10 U

Interventions

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Massive transfusion

Trauma patients who had received blood transfusion≥10 U

Intervention Type OTHER

Non-Massive Transfusion

Trauma patients who had received blood transfusion\<10 U

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMRPG8G1301

Identifier Type: -

Identifier Source: org_study_id