Non-Operative Management of High Grade Blunt Hepatic Injury: Clinical Complications and the Role of Collateral Damage (NOMLI)

June 9, 2008 updated by: University of Bern

Retrospective Single Centre Study Which Investigates the Safety of the Non-Operative Management of Patients With High Grade Blunt Liver Injuries (NOMLI) and the Impact of to the LI Collateral Intra- and Extra-Abdominal Damage on Interventions and Outcome

Little is known about the role of collateral damage in patients with high grade liver injuries (LI). This retrospective single centre study investigates the safety of the non-operative management of patients with high grade blunt liver injuries (NOMLI) and the impact of to the LI collateral intra- and extra-abdominal damage on interventions and outcome. We first hypothesized that NOMLI can be safely achieved also in high-grade liver injured patients, the management of trauma patients with LI mainly consist of the treatment of collateral damages and their complications, and causes of death are in the majority of cases not liver related. A retrospective study involving 183 patients with blunt hepatic injuries was therefore carried out to investigate these hypotheses.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Modern approach to liver injured patients favours non-operative management of liver injury (NOMLI) including endovascular artery occlusion. Numerous studies over the past two decades have confirmed the feasibility of NOMLI in up to 95% of hemodynamically stable patients with blunt trauma mechanisms. To further improve the outcome of patients with hepatic injuries, investigations should focus on the overall morbidity and mortality of NOMLI. Purely hepatic-related complication rates in most series are low, ranging from 0-7% and parallel the grade of liver lesion. But the majority of patients included in those studies suffered low-grade liver injuries (LI). Regarding the safety of NOMLI in high grade lesions, the results may be biased. Complications in patients with high-grade LI are more frequent and their management is considerably more complex. Regarding the sparsely available literature focussing on the morbidity of NOMLI in high grade LI, hepatic-related complication rates of 11 and 13% have been described. Only the LI grade and the amount of packed red blood cell (PRBC) transfusion at 24 hours postinjury predicted hepatic-related complications. No data is available concerning the impact of collateral intra- and extra-abdominal damage on complications of NOMLI in those patients. Of note, up to 75% of patients with LI suffer from collateral intra- and extra-abdominal lesions. These injuries vary in their surgical importance but severe complications and to the LI independent laparotomies must be expected in a significant number of patients. Rates of such nonspecific laparotomies have been described in up to 20% of patients with hepatic trauma. Over the past decade, overall mortality of liver injured patients remained relatively constant, averaging between 10-15%. This mortality rate represents deaths of all causes in the clinical course of these complex trauma patients. There are studies which already suggested, that early deaths in patients with LI also were caused by uncontrolled bleedings from associated intra- and extra-abdominal injuries, and that most late deaths result from collateral head injuries and sepsis with multi-organ-failure (MOF). But no detailed data about the occurrence of extra-abdominal complications after NOMLI has been published so far.

Objective:

We first hypothesized that NOMLI can be safely achieved also in high-grade liver injured patients, the management of trauma patients with LI mainly consist of the treatment of collateral damages and their complications, and causes of death are in the majority of cases not liver related. A retrospective study involving 183 patients with blunt hepatic injuries was therefore carried out to investigate these hypotheses.

Methods:

The study was conducted at the Bern University Hospital, Switzerland between January 2000 and December 2006. An average of 286 (range, 204-344) multiple injured patients were treated in our level I trauma centre each year. Only blunt liver injured patients were included. All charts (including surgery and autopsy reports) were reviewed retrospectively. Demographic data collected included age, gender, mechanism of injury. Injury patterns were defined by the Abbreviated Injury Score (AIS) and Injury Severity Score (ISS). The grade of hepatic injury was determined by an experienced radiologist and by two experienced hepatobiliary surgeons in parallel based on contrast enhanced computed tomography (CT) scan findings (Siemens® Somatom Sensation 16) or by laparotomy according to the American Association for the Surgery of Trauma Organ Injury Scale for hepatic injuries. For the current study, high-grade injuries were considered grades 3 to 5. Other data collected included the number and types of surgical procedures, hepatic-related and overall complications, and causes of deaths. All patients were managed and resuscitated using the protocols outlined in the Advanced Trauma Life Support (ATLS) manual of the American College of Surgeons Committee on Trauma. NOMLI was

Study Type

Observational

Enrollment (Actual)

183

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

      • Bern, Switzerland, 3010
        • Dep. of Visceral and Transplant Surgery, Bern University Hospital

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with blunt liver injury treated at Bern University Hospital from 2000-2006

Description

Inclusion Criteria:

  • Patients with blunt liver injury
  • Treated from 2000-2006 at Bern University Hospital

Exclusion Criteria:

  • < 16 years

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

Cohorts and Interventions

Group / Cohort
Observation
Patients with blunt liver injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: During primary in-hospital stay
During primary in-hospital stay

Secondary Outcome Measures

Outcome Measure
Time Frame
Liver-related morbidity
Time Frame: During in-hospital stay
During in-hospital stay
Other morbidity
Time Frame: During in-hospital stay
During in-hospital stay
Mortality
Time Frame: During in-hospital stay
During in-hospital stay
Surgical interventions needed
Time Frame: During in-hospital stay
During in-hospital stay

Collaborators and Investigators

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

Investigators

  • Study Director: Daniel Inderbitzin, MD, Dep. of Visceral and Transplant Surgery, Bern University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2000

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

June 6, 2008

First Submitted That Met QC Criteria

June 9, 2008

First Posted (Estimate)

June 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 10, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 29_04_2008

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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