Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma

Heart Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823160
• Other study ID #: 266/2002
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: February 18, 2011
• Start date: October 2001
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Injuries

Intervention

Procedure:
• Sternotomy
Sternotomy performed after finding blood in the pericardial sac
• Subxyphoid window
Subxyphoid window performed after the finding of blood in the pericardial sac

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

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. Epub 2005 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival at discharge till 6-months post surgery.		from surgery till 6-months post operative.	Yes
Secondary	post-operative hospital stay		until discharge	No