Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05224635 |
Other study ID # |
062.TRA.2021.D |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
December 30, 2021 |
Est. completion date |
December 30, 2024 |
Study information
Verified date |
March 2024 |
Source |
Methodist Health System |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Evidence suggests that the rate of treatable vascular injury is increasing due to improved
pre-hospital strategies. The increased rate of vascular trauma occurs in an era of increased
sub-specialization, shifting training paradigms and the emergence of endovascular therapies.
These factors, in combination with the baseline complexity of vascular trauma, make it
particularly important that the management of this injury pattern be evidence-based. However,
because all forms and distributions of vascular injury represent only 4% to 9% of trauma
admissions, meaningful study of one injury pattern, patient population, therapeutic or
surveillance strategy is difficult at a single institution. Further complicating such efforts
is the fact that vascular trauma is managed by a wide range of surgical and now endovascular
specialists, further fragmenting even a busy trauma institution's experience with vascular
injury.
Description:
Several institutions and groups have contributed important insight into the understanding of
vascular injury management. However, many of the studies have been single-institution, poorly
powered and retrospective. The lack of evidence-based practice is even more concerning given
the devastating consequences associated with mismanaged vascular trauma. In light of the
stated challenges associated with single-institution study of this injury pattern, the
logical method with which to proceed is a prospective, multicenter, observational trail. To
date no such registries exists which would allow the prospective aggregation of larger
amounts of data pertaining to all phases of vascular trauma management.
Contemporary experience confirms that the management of vascular injury is more complicated
than in the past. A multitude of new or updated diagnostic technologies including computed
tomography angiography (CTA), magnetic resonance angiography (MRA), duplex and arteriography
now exist and are in various degrees of vogue. A damage control approach to vascular trauma
is widely championed and includes options for the use of tourniquets, temporary vascular
shunts and fasciotomies. Controversies regarding the definitive management of vascular trauma
abound and include the advisability of open versus endovascular treatment, decisions about
the type of vascular conduit and the utility of venous injury repair lo list a few.
Recommendations for surveillance after vascular trauma may include the use of duplex
ultrasound or CTA to confirm long-term patency as well as choices related to the use of
long-term anti-thrombotic therapy. Finally, it is not uncommon for an institution to find
itself facing many of these decision points in the most challenging of all scenarios, the
extremes of age including pediatric vascular injury.