NCT03485573

Brief Summary

Every year more people die from traumatic injuries than from infections such as malaria, tuberculosis, and HIV/AIDS. About 3000 people are killed annually on Kenyan roads. Hospital trauma registers have played a key role in the advancement of patient-based research and trauma care. Trauma registers offer a unique opportunity to document patient characteristics and audit outcomes, thereby creating a platform for clinical research. One of these systems is the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death. The establishment of the register enables us to compare the trauma care quality with other existing or upcoming trauma registers, in different settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

March 19, 2018

Last Update Submit

October 7, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Score injury severity with the aim of improving trauma care by using the ICD-based Injury Severity Score (ICISS) derived from and validated on hospital data to predict hospital death.

    To calculate ICISS, each ICD-code is assigned a survival risk ratios (SRR), which represents a true continuous variable that takes on values between 0 and 1. SRR is based on the assumption that a patient's probability of survival can be predicted based on the survival rates of prior patients with similar injuries as classified by the ICD-10. The ICISS value is the product of SRRs from each injury sustained. A multiplicative prediction model with an assumption that all injuries contribute to the overall severity. The SRR for each code is empirically derived from the upcoming patient data. To obtain ICISS, SRRs of all injuries are multiplied. ICISS = SRRinj1 × SRRinj2 × SRRinj3 × SRRinj4. Create a ICISS trauma registry is valuable to document epidemiology, process and outcome, thus enabling the measurement of the impact of trauma care following injury.

    two years

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.

You may qualify if:

  • Trauma patients of ages 14 and above admitted to the ED at MTRH will be included in the study.

You may not qualify if:

  • Those brought in dead, revisits, or referred patients will excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi Teaching and Referral Hospital, Kenya.

Eldoret, 30100, Kenya

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, RN, PhD

Study Record Dates

First Submitted

March 19, 2018

First Posted

April 2, 2018

Study Start

May 8, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations