Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823160
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : February 21, 2011
Medical Research Council, South Africa
Information provided by:
University of Cape Town

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.

Condition or disease Intervention/treatment Phase
Heart Injuries Procedure: Sternotomy Procedure: Subxyphoid window Not Applicable

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2001
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. survival at discharge till 6-months post surgery. [ Time Frame: from surgery till 6-months post operative. ]

Secondary Outcome Measures :
  1. post-operative hospital stay [ Time Frame: until discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823160

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
Principal Investigator: Andrew J Nicol, MD University of Cape Town

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Associate Professor Andrew Nicol, University of Cape Town Identifier: NCT00823160     History of Changes
Other Study ID Numbers: 266/2002
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: April 2009

Keywords provided by University of Cape Town:
Pericardial window

Additional relevant MeSH terms:
Heart Injuries
Thoracic Injuries
Wounds and Injuries