Effect of Hypocalcemia on the Outcome of Elderly Major Trauma Patients With Trauma-induced Coagulopathy

September 6, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This 5-year retrospective, observational, single-center study was conducted at the Second Affiliated Hospital of Zhejiang University Medical School (SAHZU, China). Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020.The purpose of this study is to elucidate the effect of hypocalcemia on TIC in elderly trauma patients through a single-center retrospective study, so as to further optimize the diagnosis and treatment strategies for TIC in elderly trauma patients.

Study Type

Observational

Enrollment (Anticipated)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 98 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Elderly patients with trauma were registered when they were admitted into intensive care unit affiliated to department of Emergency medicine (EICU) since January 2015 and September 2020

Description

Inclusion Criteria:

  • age≥65 years old
  • history of trauma

Exclusion Criteria:

  • previous anticoagulants or antiplatelet medication;
  • Coagulopathy caused by previous underlying diseases;
  • Blood products transfused before admission;
  • Cardiac arrest on admission;
  • Malignant tumor;
  • Data incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
trauma induced coagulopathy
patients with INR>1.2
Other: hypocalcemia
hypocalcemia or normocalcemia
non-trauma induced coagulopathy
patients with INR≤1.2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internationalized Normalized Ratio (INR)
Time Frame: 24 hour
coagulation function :Internationalized Normalized Ratio (INR)
24 hour
Activated Partial Thromboplastin Time (APTT)
Time Frame: 24 hour
coagulation function : Activated Partial Thromboplastin Time (APTT)
24 hour
Prothrombin Time (PT)
Time Frame: 24 hour
coagulation function : Prothrombin Time (PT)
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood products rate
Time Frame: through study completion, an average of 1 week
the rate of Blood products use
through study completion, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: yongan xu, doctor, Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 6, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-822

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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