Delta Shock Index in Predicting Massive Transfusion

Trauma Patients Had Not Received Blood Transfusion = 10 U Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03786705
• Other study ID #: CMRPG8G1301
• Status: Completed
• Start date: June 5, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: December 2018
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7957
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Trauma Patients Had Not Received Blood Transfusion = 10 U
• Trauma Patients Received Blood Transfusion = 10 U
• Wounds and Injuries

Intervention

Other:
• Massive transfusion
Trauma patients who had received blood transfusion=10 U
• Non-Massive Transfusion
Trauma patients who had received blood transfusion<10 U

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality	To measure the outcome of patients.	up to 5 months