NCT05530161

Brief Summary

Hypocalcaemia is an independent risk factor of TIC in elderly trauma patients. TIC combined with hypocalcemia had worse coagulation function and more serious acidosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

September 7, 2022

Status Verified

August 1, 2022

Enrollment Period

8.7 years

First QC Date

August 30, 2022

Last Update Submit

September 6, 2022

Conditions

CoagulopathyTrauma

Keywords

trauma

Outcome Measures

Primary Outcomes (3)

  • Internationalized Normalized Ratio (INR)

    coagulation function :Internationalized Normalized Ratio (INR)

    24 hour

  • Activated Partial Thromboplastin Time (APTT)

    coagulation function : Activated Partial Thromboplastin Time (APTT)

    24 hour

  • Prothrombin Time (PT)

    coagulation function : Prothrombin Time (PT)

    24 hour

Secondary Outcomes (1)

  • Blood products rate

    through study completion, an average of 1 week

Study Arms (2)

trauma induced coagulopathy

patients with INR\>1.2

Other: hypocalcemia

non-trauma induced coagulopathy

patients with INR≤1.2

Interventions

hypocalcemiaOTHER

hypocalcemia or normocalcemia

trauma induced coagulopathy

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • age≥65 years old
  • history of trauma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAHZU

Hanzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Hemostatic DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • yongan xu, doctor

    Department of Emergency medicine，Second Affiliated Hospitalof Zhejiang University

    STUDY CHAIR

Central Study Contacts

yongan xu, doctor

CONTACT

13757164833xuyongan2000@163.com

yangbo kang, master

CONTACT

198588788031179619719@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 7, 2022

Study Start

January 1, 2015

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

September 7, 2022

Record last verified: 2022-08

Locations

CN(1)