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OpenTrials
Completed

NCT Number: NCT03786705

Delta Shock Index in Predicting Massive Transfusion

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.

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Key information

Conditions

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

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massive transfusion

Other

Trauma patients who had received blood transfusion≥10 U

Non-Massive Transfusion

Other

Trauma patients who had received blood transfusion<10 U

Primary outcomes

  1. in-hospital mortality

    Time frame: up to 5 months

    To measure the outcome of patients.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.