Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03133338
Other study ID # TSGHIRB No. 1-103-05-122
Secondary ID
Status Completed
Phase N/A
First received April 25, 2017
Last updated April 28, 2017
Start date August 1, 2013
Est. completion date July 31, 2014

Study information

Verified date April 2017
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators aimed to evaluate the effect of early pelvic binder use in emergency management of suspected pelvic trauma, compared with the conventional stepwise approach.


Description:

There is currently no universal consensus on all aspects of management of pelvic injuries.

Among patients with multiple injuries because of blunt trauma, 5%-16% sustain injuries to the pelvic ring, resulting in a mortality rate of 11%-54% primarily due to hemorrhagic shock. In theory, the reduction and stabilization of the pelvic ring can decrease bleeding from the fracture site, as reduction of pelvic volume has been shown to reduce the extent of hemorrhage from such injuries.The application of a pelvic binder has become part of the emergency care of all trauma patients with suspected pelvic fractures, in both the pre-hospital environment and emergency department (ED). The present study aimed to assess the effectiveness of the early use of pelvic binders to treat patients with a suspected high risk of pelvic bleeding from blunt force pelvic fractures.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date July 31, 2014
Est. primary completion date July 31, 2014
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- Traumatic injury requiring a trauma team and at least one of the following: loss of consciousness or Glasgow coma score (GCS) < 13; systolic blood pressure < 90 mmHg; falling from =6 m; injury to multiple vital organs; and suspected pelvic injury. -

Exclusion Criteria:

- Not meet the criteria and loss follow up (transfer to other hospital or data not available) -

Study Design


Related Conditions & MeSH terms


Intervention

Device:
pelvic binder
The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tri-Service General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Blood transfusion Pelvic fracture with hemodynamic unstable admission
Secondary admission mortality mortality in the same admission mortality in the same admission
See also
  Status Clinical Trial Phase
Recruiting NCT05606042 - Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
Not yet recruiting NCT06054165 - Impact of a Clinical Pathway for Pelvic Fragility Fractures N/A
Recruiting NCT04744350 - Conservative or Operative Therapy in Patients With a Fragility Fracture of the Pelvis N/A
Enrolling by invitation NCT03977168 - A Prospective Study of Early Mechanical Stabilization and Bleeding in Disruption of the Pelvic Ring
Completed NCT03475771 - Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery
Active, not recruiting NCT05354531 - Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions N/A
Completed NCT06388915 - A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion
Active, not recruiting NCT05836727 - Use of Laparoscopy in the Treatment of Pelvic Ring Ruptures
Recruiting NCT04182776 - Fragility Fractures of the Pelvis (FFP)
Not yet recruiting NCT03944174 - Single Trans-sacral Screw Versus Two Iliosacral Screws
Not yet recruiting NCT05448911 - The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures N/A
Completed NCT02855060 - Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis N/A
Recruiting NCT05367505 - Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis N/A
Completed NCT04217499 - Pelvic Ring Fractures: New Analysis Method and Treatment Decision Algorithm
Terminated NCT00594906 - Use of Teriparatide to Accelerate Fracture Healing N/A
Completed NCT04303442 - Corona Mortis in Patients Undergoing TEP for Inguinal Hernia
Enrolling by invitation NCT05712850 - Clinical Outcome and Fusion Results Using the SiJoin® Transfixing Sacroiliac Fusion Device
Recruiting NCT04937868 - Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients
Withdrawn NCT04764864 - Pelvic Fractures in Polytraumatized Patients With Hemodynamic Instability: Angioembolization vs Preperitoneal Packing N/A
Recruiting NCT04615104 - Pelvic and Acetabular Fracture: A Prospective Observational Study