NCT00694499

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2000

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2008

Completed
Last Updated

June 10, 2008

Status Verified

June 1, 2008

First QC Date

June 6, 2008

Last Update Submit

June 9, 2008

Conditions

Liver Injury

Keywords

MorbidityMortality

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    During primary in-hospital stay

Secondary Outcomes (4)

  • Liver-related morbidity

    During in-hospital stay

  • Other morbidity

    During in-hospital stay

  • Mortality

    During in-hospital stay

  • Surgical interventions needed

    During in-hospital stay

Study Arms (1)

Observation

Patients with blunt liver injury

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \< 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Visceral and Transplant Surgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (10)

  • 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.

    PMID: 1486439BACKGROUND

  • Velmahos 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.

    PMID: 12742948BACKGROUND

  • Pachter 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.

    PMID: 8576995BACKGROUND

  • Kozar 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.

    PMID: 16702516BACKGROUND

  • Kozar 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.

    PMID: 16385280BACKGROUND

  • Gao 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.

    PMID: 12733001BACKGROUND

  • Hurtuk 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.

    PMID: 16917435BACKGROUND

  • Resources 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.

    PMID: 10106239BACKGROUND

  • Baker 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.

    PMID: 4814394BACKGROUND

  • Cogbill 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.

    PMID: 3172301BACKGROUND

Study Officials

  • Daniel Inderbitzin, MD

    Dep. of Visceral and Transplant Surgery, Bern University Hospital Bern

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2008

First Posted

June 10, 2008

Study Start

January 1, 2000

Study Completion

December 1, 2006

Last Updated

June 10, 2008

Record last verified: 2008-06

Locations

CH(1)