NCT00823160

Brief Summary

Penetrating wounds to the heart may present to the emergency unit with the presence of blood in the pericardial sac as determined on ultrasound. If these patients are stable, the study hypothesis is that they can be managed with a very simple surgical procedure called a subxyphoid pericardial window (SXW), in which the blood is drained from around the heart via a small skin incision below the rib cage. In all other centres in the world these cases are managed by open chest surgery called a sternotomy. The investigator's experience in dealing with these injuries is that this is unnecessary and requires a large amount of resources for no benefit to the patient. In this study, patients are randomized to receive either open chest surgery (sternotomy) or the much smaller operation of the SXW. The patients are then followed up with respect to their hospital stay and any complications that they develop. Normally, a patient undergoing open chest surgery will stay in intensive care unit for a minimum of 2 days and have a total hospital stay of at least 7 days and be at risk of a number of complications such as pneumonia. Patients undergoing a SXW usually remain in hospital for a period of 3 days and do not require intensive care management. The investigator's hypothesis is that in all these patients the heart injury has sealed and the patient is no longer in any danger. It is not necessary to perform open chest surgery on these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable

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

October 1, 2001

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 21, 2011

Status Verified

April 1, 2009

Enrollment Period

7.3 years

First QC Date

January 14, 2009

Last Update Submit

February 18, 2011

Conditions

Heart Injuries

Keywords

Pericardial windowSternotomyHaemopericardium

Outcome Measures

Primary Outcomes (1)

  • survival at discharge till 6-months post surgery.

    from surgery till 6-months post operative.

Secondary Outcomes (1)

  • post-operative hospital stay

    until discharge

Study Arms (2)

1: Sternotomy

ACTIVE COMPARATOR

Patients who are randomized to a sternotomy after the finding of blood in the pericardial sac.

Procedure: Sternotomy

2: Subxyphoid window

ACTIVE COMPARATOR

Patients who receive a subxyphoid window after the finding of blood in the pericardial sac.

Procedure: Subxyphoid window

Interventions

SternotomyPROCEDURE

Sternotomy performed after finding blood in the pericardial sac

1: Sternotomy
Subxyphoid windowPROCEDURE

Subxyphoid window performed after the finding of blood in the pericardial sac

2: Subxyphoid window

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Haemodynamically stable
  • Penetrating chest trauma
  • Informed consent signed
  • Over the age of 18 years
  • Fully conscious

You may not qualify if:

  • Known coagulopathy
  • Traumatic septal defect
  • Haemodynamically unstable
  • No informed consent
  • Decreased level of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cape Town

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (2)

  • Navsaria PH, Nicol AJ. Haemopericardium in stable patients after penetrating injury: is subxiphoid pericardial window and drainage enough? A prospective study. Injury. 2005 Jun;36(6):745-50. doi: 10.1016/j.injury.2004.08.005. Epub 2005 Mar 28.

    PMID: 15910827BACKGROUND

  • Nicol AJ, Navsaria PH, Hommes M, Ball CG, Edu S, Kahn D. Sternotomy or drainage for a hemopericardium after penetrating trauma: a randomized controlled trial. Ann Surg. 2014 Mar;259(3):438-42. doi: 10.1097/SLA.0b013e31829069a1.

    PMID: 23604058DERIVED

MeSH Terms

Conditions

Heart InjuriesPericardial Effusion

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Thoracic InjuriesWounds and InjuriesHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Andrew J Nicol, MD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

October 1, 2001

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 21, 2011

Record last verified: 2009-04

Locations

ZA(1)