Heart InjuriesNCT00823160
Surgical Management of Blood in the Pericardial Sac After Penetrating Trauma
A study testing Sternotomy and Subxyphoid window in people with Heart Injuries, run by University of Cape Town at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Injuries
- What is being tested?
- Sternotomy and Subxyphoid window
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2001to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Haemodynamically stable
- Penetrating chest trauma
- Informed consent signed
- Over the age of 18 years
- Fully conscious
Who cannot join
- Known coagulopathy
- Traumatic septal defect
- Haemodynamically unstable
- No informed consent
- Decreased level of consciousness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Injuries
- Being tested
- Sternotomy, Subxyphoid window
- Keywords
- Pericardial window, Sternotomy, Haemopericardium
- Medical subject headings
- Heart Injuries, Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SternotomyProcedure or surgery
Sternotomy performed after finding blood in the pericardial sac
Subxyphoid windowProcedure or surgery
Subxyphoid window performed after the finding of blood in the pericardial sac
| Study group | Role | What they receive |
|---|---|---|
| 1: Sternotomy | Active comparator | Patients who are randomized to a sternotomy after the finding of blood in the pericardial sac. Receives: Procedure: Sternotomy |
| 2: Subxyphoid window | Active comparator | Patients who receive a subxyphoid window after the finding of blood in the pericardial sac. Receives: Procedure: Subxyphoid window |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival at discharge till 6-months post surgery.
Measured: from surgery till 6-months post operative.
Secondary outcomes (1)
post-operative hospital stay
Measured: until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startOct 2001
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Investigators
- Andrew J Nicol, MD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823160
- Sponsor's protocol ID
- 266/2002
- Status last verified
- Apr 2009
- First submitted
- 14 Jan 2009
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15910827Nicol 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.
PubMed 23604058
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Study of the Definitive Management of the Stable Haemopericardium Following Penetrating Cardiac Injury Utilising Subxyphoid Window and Drainage.
- ClinicalTrials.gov ID
- NCT00823160
- Acronym / sponsor ID
- 266/2002
- Conditions
- Heart Injuries
- Keywords
- Pericardial window, Sternotomy, Haemopericardium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- Oct 2001
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Sternotomy | Active comparator | Procedure: SternotomyPatients who are randomized to a sternotomy after the finding of blood in the pericardial sac. |
| 2: Subxyphoid window | Active comparator | Procedure: Subxyphoid windowPatients who receive a subxyphoid window after the finding of blood in the pericardial sac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Haemodynamically stable
- Penetrating chest trauma
- Informed consent signed
- Over the age of 18 years
- Fully conscious
Key exclusion criteria (5 listed)
- Known coagulopathy
- Traumatic septal defect
- Haemodynamically unstable
- No informed consent
- Decreased level of consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SternotomySternotomy performed after finding blood in the pericardial sac | Procedure or surgery | 1: Sternotomy |
| Subxyphoid windowSubxyphoid window performed after the finding of blood in the pericardial sac | Procedure or surgery | 2: Subxyphoid window |
Primary outcome
survival at discharge till 6-months post surgery.
Time frame: from surgery till 6-months post operative.
1 secondary outcome
post-operative hospital stay
Time frame: until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Background: PubMed 15910827Navsaria 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.
- Derived from this study: PubMed 23604058Nicol 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Nicol, MD principal investigator
University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sternotomy and Subxyphoid window in people with Heart Injuries, run by University of Cape Town at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival at discharge till 6-months post surgery. (time frame: from surgery till 6-months post operative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00823160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.