Liver InjuryNOMLINCT00694499
Non-Operative Management of High Grade Blunt Hepatic Injury: Clinical Complications and the Role of Collateral Damage
An observational study of Liver Injury, run by University of Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Injury
- How many people
- 183 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2000to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with blunt liver injury treated at Bern University Hospital from 2000-2006
Who may be able to join
- Patients with blunt liver injury
- Treated from 2000-2006 at Bern University Hospital
Who cannot join
- < 16 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Visceral and Transplant Surgery, Bern University Hospital
Bern, 3010
About this study
Official title: 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.
Read the 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
- Conditions
- Liver Injury
- Keywords
- Morbidity, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Patients with blunt liver injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Measured: During primary in-hospital stay
Secondary outcomes (4)
Liver-related morbidity
Measured: During in-hospital stay
Other morbidity
Measured: During in-hospital stay
Mortality
Measured: During in-hospital stay
Surgical interventions needed
Measured: During in-hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJan 2000
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Liver InjuryStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Inderbitzin, MD, Study director, Dep. of Visceral and Transplant Surgery, Bern University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694499
- Sponsor's protocol ID
- KEK 29_04_2008
- Acronym
- NOMLI
- Status last verified
- Jun 2008
- First submitted
- 6 Jun 2008
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
John TG, Greig JD, Johnstone AJ, Garden OJ. Liver trauma: a 10-year experience. Br J Surg. 1992 Dec;79(12):1352-6. doi: 10.1002/bjs.1800791238.
PubMed 1486439Velmahos GC, Toutouzas K, Radin R, Chan L, Rhee P, Tillou A, Demetriades D. High success with nonoperative management of blunt hepatic trauma: the liver is a sturdy organ. Arch Surg. 2003 May;138(5):475-80; discussion 480-1. doi: 10.1001/archsurg.138.5.475.
PubMed 12742948Pachter HL, Knudson MM, Esrig B, Ross S, Hoyt D, Cogbill T, Sherman H, Scalea T, Harrison P, Shackford S, et al. Status of nonoperative management of blunt hepatic injuries in 1995: a multicenter experience with 404 patients. J Trauma. 1996 Jan;40(1):31-8. doi: 10.1097/00005373-199601000-00007.
PubMed 8576995Kozar RA, Moore FA, Cothren CC, Moore EE, Sena M, Bulger EM, Miller CC, Eastridge B, Acheson E, Brundage SI, Tataria M, McCarthy M, Holcomb JB. Risk factors for hepatic morbidity following nonoperative management: multicenter study. Arch Surg. 2006 May;141(5):451-8; discussion 458-9. doi: 10.1001/archsurg.141.5.451.
PubMed 16702516Kozar RA, Moore JB, Niles SE, Holcomb JB, Moore EE, Cothren CC, Hartwell E, Moore FA. Complications of nonoperative management of high-grade blunt hepatic injuries. J Trauma. 2005 Nov;59(5):1066-71. doi: 10.1097/01.ta.0000188937.75879.ab.
PubMed 16385280Gao JM, Du DY, Zhao XJ, Liu GL, Yang J, Zhao SH, Lin X. Liver trauma: experience in 348 cases. World J Surg. 2003 Jun;27(6):703-8. doi: 10.1007/s00268-003-6573-z. Epub 2003 May 13.
PubMed 12733001Hurtuk M, Reed RL 2nd, Esposito TJ, Davis KA, Luchette FA. Trauma surgeons practice what they preach: The NTDB story on solid organ injury management. J Trauma. 2006 Aug;61(2):243-54; discussion 254-5. doi: 10.1097/01.ta.0000231353.06095.8d.
PubMed 16917435Resources for optimal care of the injured patient: an update. Task Force of the Committee on Trauma, American College of Surgeons. Bull Am Coll Surg. 1990 Sep;75(9):20-9. No abstract available.
PubMed 10106239Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
PubMed 4814394Cogbill TH, Moore EE, Jurkovich GJ, Feliciano DV, Morris JA, Mucha P. Severe hepatic trauma: a multi-center experience with 1,335 liver injuries. J Trauma. 1988 Oct;28(10):1433-8.
PubMed 3172301
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00694499
- Acronym / sponsor ID
- NOMLI / KEK 29_04_2008
- Conditions
- Liver Injury
- Keywords
- Morbidity, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | –Patients with blunt liver injury |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with blunt liver injury treated at Bern University Hospital from 2000-2006
Key inclusion criteria (2 listed)
- Patients with blunt liver injury
- Treated from 2000-2006 at Bern University Hospital
Key exclusion criteria (1 listed)
- < 16 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Morbidity
Time frame: During primary in-hospital stay
4 secondary outcomes
Liver-related morbidity
Time frame: During in-hospital stay
Other morbidity
Time frame: During in-hospital stay
Mortality
Time frame: During in-hospital stay
Surgical interventions needed
Time frame: During in-hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2008.
- Background: PubMed 1486439John TG, Greig JD, Johnstone AJ, Garden OJ. Liver trauma: a 10-year experience. Br J Surg. 1992 Dec;79(12):1352-6. doi: 10.1002/bjs.1800791238.
- Background: PubMed 12742948Velmahos GC, Toutouzas K, Radin R, Chan L, Rhee P, Tillou A, Demetriades D. High success with nonoperative management of blunt hepatic trauma: the liver is a sturdy organ. Arch Surg. 2003 May;138(5):475-80; discussion 480-1. doi: 10.1001/archsurg.138.5.475.
- Background: PubMed 8576995Pachter HL, Knudson MM, Esrig B, Ross S, Hoyt D, Cogbill T, Sherman H, Scalea T, Harrison P, Shackford S, et al. Status of nonoperative management of blunt hepatic injuries in 1995: a multicenter experience with 404 patients. J Trauma. 1996 Jan;40(1):31-8. doi: 10.1097/00005373-199601000-00007.
- Background: PubMed 16702516Kozar RA, Moore FA, Cothren CC, Moore EE, Sena M, Bulger EM, Miller CC, Eastridge B, Acheson E, Brundage SI, Tataria M, McCarthy M, Holcomb JB. Risk factors for hepatic morbidity following nonoperative management: multicenter study. Arch Surg. 2006 May;141(5):451-8; discussion 458-9. doi: 10.1001/archsurg.141.5.451.
- Background: PubMed 16385280Kozar RA, Moore JB, Niles SE, Holcomb JB, Moore EE, Cothren CC, Hartwell E, Moore FA. Complications of nonoperative management of high-grade blunt hepatic injuries. J Trauma. 2005 Nov;59(5):1066-71. doi: 10.1097/01.ta.0000188937.75879.ab.
- Background: PubMed 12733001Gao JM, Du DY, Zhao XJ, Liu GL, Yang J, Zhao SH, Lin X. Liver trauma: experience in 348 cases. World J Surg. 2003 Jun;27(6):703-8. doi: 10.1007/s00268-003-6573-z. Epub 2003 May 13.
- Background: PubMed 16917435Hurtuk M, Reed RL 2nd, Esposito TJ, Davis KA, Luchette FA. Trauma surgeons practice what they preach: The NTDB story on solid organ injury management. J Trauma. 2006 Aug;61(2):243-54; discussion 254-5. doi: 10.1097/01.ta.0000231353.06095.8d.
- Background: PubMed 10106239Resources for optimal care of the injured patient: an update. Task Force of the Committee on Trauma, American College of Surgeons. Bull Am Coll Surg. 1990 Sep;75(9):20-9. No abstract available.
- Background: PubMed 4814394Baker SP, O'Neill B, Haddon W Jr, Long WB. The injury severity score: a method for describing patients with multiple injuries and evaluating emergency care. J Trauma. 1974 Mar;14(3):187-96. No abstract available.
- Background: PubMed 3172301Cogbill TH, Moore EE, Jurkovich GJ, Feliciano DV, Morris JA, Mucha P. Severe hepatic trauma: a multi-center experience with 1,335 liver injuries. J Trauma. 1988 Oct;28(10):1433-8.
Related trials for Liver Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Inderbitzin, MD study director
Dep. of Visceral and Transplant Surgery, Bern University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Injury, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: During primary in-hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00694499, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2008.