Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma
Primary Purpose
Heart Injuries
Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Sternotomy
Subxyphoid window
Sponsored by
About this trial
This is an interventional treatment trial for Heart Injuries focused on measuring Pericardial window, Sternotomy, Haemopericardium
Eligibility 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
Sites / Locations
- University of Cape Town
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1: Sternotomy
2: Subxyphoid window
Arm Description
Patients who are randomized to a sternotomy after the finding of blood in the pericardial sac.
Patients who receive a subxyphoid window after the finding of blood in the pericardial sac.
Outcomes
Primary Outcome Measures
survival at discharge till 6-months post surgery.
Secondary Outcome Measures
post-operative hospital stay
Full Information
NCT ID
NCT00823160
First Posted
January 14, 2009
Last Updated
February 18, 2011
Sponsor
University of Cape Town
Collaborators
Medical Research Council, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT00823160
Brief Title
Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma
Official Title
A Randomized Prospective Study of the Definitive Management of the Stable Haemopericardium Following Penetrating Cardiac Injury Utilising Subxyphoid Window and Drainage.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cape Town
Collaborators
Medical Research Council, South Africa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Injuries
Keywords
Pericardial window, Sternotomy, Haemopericardium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Sternotomy
Arm Type
Active Comparator
Arm Description
Patients who are randomized to a sternotomy after the finding of blood in the pericardial sac.
Arm Title
2: Subxyphoid window
Arm Type
Active Comparator
Arm Description
Patients who receive a subxyphoid window after the finding of blood in the pericardial sac.
Intervention Type
Procedure
Intervention Name(s)
Sternotomy
Intervention Description
Sternotomy performed after finding blood in the pericardial sac
Intervention Type
Procedure
Intervention Name(s)
Subxyphoid window
Intervention Description
Subxyphoid window performed after the finding of blood in the pericardial sac
Primary Outcome Measure Information:
Title
survival at discharge till 6-months post surgery.
Time Frame
from surgery till 6-months post operative.
Secondary Outcome Measure Information:
Title
post-operative hospital stay
Time Frame
until discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Nicol, MD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cape Town
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Citations:
PubMed Identifier
15910827
Citation
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.
Results Reference
background
PubMed Identifier
23604058
Citation
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.
Results Reference
derived
Learn more about this trial
Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma
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