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Delta Shock Index in Predicting Massive Transfusion

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ClinicalTrials.gov Identifier: NCT03786705
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.


Condition or disease Intervention/treatment
Trauma Patients Received Blood Transfusion ≥ 10 U Trauma Patients Had Not Received Blood Transfusion ≥ 10 U Other: Massive transfusion Other: Non-Massive Transfusion

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Study Type : Observational
Actual Enrollment : 7957 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients
Actual Study Start Date : June 5, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
Other: Massive transfusion
Trauma patients who had received blood transfusion≥10 U

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




Primary Outcome Measures :
  1. in-hospital mortality [ Time Frame: up to 5 months ]
    To measure the outcome of patients.



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786705


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03786705     History of Changes
Other Study ID Numbers: CMRPG8G1301
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries