Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Delta Shock Index in Predicting Massive Transfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 21, 2018
First Posted Date December 25, 2018
Last Update Posted Date December 25, 2018
Actual Study Start Date June 5, 2018
Actual Primary Completion Date December 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2018)
in-hospital mortality [ Time Frame: up to 5 months ]
To measure the outcome of patients.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Delta Shock Index in Predicting Massive Transfusion
Official Title The Relationship of Delta Shock Index With the Requirement of Blood Transfusion and Clinical Outcome of Adult Trauma Patients
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Trauma Patients Received Blood Transfusion ≥ 10 U
  • Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
Intervention
  • 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
Study Groups/Cohorts 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).
Interventions:
  • Other: Massive transfusion
  • Other: Non-Massive Transfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2018)
7957
Original Actual Enrollment Same as current
Actual Study Completion Date December 20, 2018
Actual Primary Completion Date December 20, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03786705
Other Study ID Numbers CMRPG8G1301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor Chang Gung Memorial Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Chang Gung Memorial Hospital
Verification Date December 2018