Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma

February 18, 2011 updated by: University of Cape Town

A Randomized Prospective Study of the Definitive Management of the Stable Haemopericardium Following Penetrating Cardiac Injury Utilising Subxyphoid Window and Drainage.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7925
        • University of Cape Town

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival at discharge till 6-months post surgery.
Time Frame: from surgery till 6-months post operative.
from surgery till 6-months post operative.

Secondary Outcome Measures

Outcome Measure
Time Frame
post-operative hospital stay
Time Frame: until discharge
until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cape Town

Collaborators

Medical Research Council, South Africa

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (ACTUAL)

February 1, 2009

Study Completion (ACTUAL)

February 1, 2009

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (ESTIMATE)

January 15, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 21, 2011

Last Update Submitted That Met QC Criteria

February 18, 2011

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 266/2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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