Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council, South Africa
Information provided by:
University of Cape Town
ClinicalTrials.gov Identifier:
NCT00823160
First received: January 14, 2009
Last updated: February 18, 2011
Last verified: April 2009
  Purpose

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.


Condition Intervention
Heart Injuries
Procedure: Sternotomy
Procedure: Subxyphoid window

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Prospective Study of the Definitive Management of the Stable Haemopericardium Following Penetrating Cardiac Injury Utilising Subxyphoid Window and Drainage.

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • survival at discharge till 6-months post surgery. [ Time Frame: from surgery till 6-months post operative. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • post-operative hospital stay [ Time Frame: until discharge ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: October 2001
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1: Sternotomy
Patients who are randomized to a sternotomy after the finding of blood in the pericardial sac.
Procedure: Sternotomy
Sternotomy performed after finding blood in the pericardial sac
Active Comparator: 2: Subxyphoid window
Patients who receive a subxyphoid window after the finding of blood in the pericardial sac.
Procedure: Subxyphoid window
Subxyphoid window performed after the finding of blood in the pericardial sac

Detailed Description:

Introduction:

This will be the first prospective, randomized clinical study ever performed on penetrating cardiac injuries in the world literature. A group of patients with penetrating chest injuries will present haemodynamically stable, with blood in the pericardial sac diagnosed on ultrasound. The accepted international management of what is termed; "the stable haemopericardium" has been a median sternotomy. In our experience in Cape Town, when a median sternotomy is performed in these cases, any cardiac injury if present has already sealed or there is no cardiac injury. We feel that these patients should be managed with a much smaller and simpler operation that does not require admission to the intensive care unit post-operatively and this is merely drainage of the blood from around the pericardial sac via a subxyphoid window (SXW).

Method A SXW is performed under general anaesthetic and involves a 5 cm incision below the sternum. The pericardial sac can be opened and the blood drained. This small operation also allows the heart to be examined for any active bleeding. If there is active bleeding then obviously, a median sternotomy is required to fix the hole in the heart. If there is no active bleeding then the patient is randomized to either median sternotomy (the international norm) or the pericardial sac is merely drained with a soft drain and no further surgery is performed. The randomization is computer generated. The patients are documented with respect to intensive care stay and total hospital stay. Any complications are noted and the patients are then followed up in order to ensure that the patients who underwent the SXW alone are alive and well. This is essential to ensure the safety of this much smaller procedure for this condition. Informed consent is signed for each patient and all patients must be older than 18 years of age.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Known coagulopathy
  • Traumatic septal defect
  • Haemodynamically unstable
  • No informed consent
  • Decreased level of consciousness
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00823160

Locations
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Medical Research Council, South Africa
Investigators
Principal Investigator: Andrew J Nicol, MD University of Cape Town
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Andrew Nicol, University of Cape Town
ClinicalTrials.gov Identifier: NCT00823160     History of Changes
Other Study ID Numbers: 266/2002
Study First Received: January 14, 2009
Last Updated: February 18, 2011
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:
Pericardial window
Sternotomy
Haemopericardium

Additional relevant MeSH terms:
Heart Injuries
Pericardial Effusion
Wounds and Injuries
Thoracic Injuries
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014