Plain English Summary
Background and study aims
Massive bleeding after severe trauma with pelvis bone fractures is a fatal condition if not treated urgently. Both open surgical bleeding control and minimally invasive clotting of bleeding vessels are well established methods to deal with this condition. Until now it is unclear which method is superior. This study aims at comparing mortality, complications and treatment delay for the two methods.
Who can participate?
Adult patients between 18 and 65 years of age with pelvic fracture, severe multiple injuries, and massive blood loss are included in this study. Due to the acute selection of patients, no active recruiting of patients will be performed.
What does the study involve?
This study compares angioembolization and retroperitoneal pelvic packing for bleeding due to pelvic fractures. For angioembolization a wire is placed in a blood vessel and guided by x-ray to the bleeding vessel, which can be clotted from inside. Retroperitoneal pelvic packing uses an open surgical approach, where the bleeding vessels are ligated (tied off) and/or directly compressed. Sometimes patients with angioembolization require additional pelvic packing and vice versa. If necessary this secondary procedure will be performed and registered. Apart from this intervention all patients will receive the same treatment.
What are the possible benefits and risks of participating?
Patients enrolled in this study will be followed meticulously and will thus receive maximum attention of the surgical team. Until now there are no studies documenting one method being superior over the other. Common adverse effects of angioembolization are injection site infections and allergic reactions to contrast media (substances used to improve images of the inside of the body in medical imaging). The most common adverse event of pelvic packing is a deep infection.
Where is the study run from?
This is a single-center study, run by the Shandong Provincial Hospital in Jinan, China.
When is the study starting and how long is it expected to run for?
February 2003 to February 2013.
Who is funding the study?
This study has no external funding. The treatment costs are covered by the Chinese government.
Who is the main contact?
Prof. Zhou Dongsheng
Tel: New Hospital:+86 (0)531 6877 3195, Old Hospital: +86 (0)531 6877 6382
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Retroperitoneal packing or angioembolization for hemorrhage control of pelvic fractures - quasi-randomized clinical trial of hemodynamically unstable patients with Injury Severity Score ≥ 33
Acronym
Study hypothesis
In patients with pelvic fracture uncontrollable bleeding is the major cause of death within the first 24h after injury. Early hemorrhage control is therefore vital for successful treatment. Nowadays, recommended techniques for hemorrhage control in pelvic fractures are retroperitoneal pelvic packing and angioembolization, dependent upon the available technical staff and resources and the condition of the patient.
Is retroperitoneal pelvic packing or angiography superior with regard to in-hospital mortality, complications, required secondary procedures, or post-intervention blood loss? Which of these methods is the more rapid intervention in the acute setting?
Ethics approval
Shandong University Institutional Review Board, January 2003, no. 201252
Study design
Single-center interventional quasi-randomized controlled trial with parallel design
Primary study design
Interventional
Secondary study design
Quasi-randomized design
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pelvic fracture
Intervention
Angiography (ANGIO)
Patients with persistent hemodynamic instability (systolic blood pressure (SBP) <90 mmHg after the transfusion of 4 packed red blood cell (PRBC) units in the emergency department) are taken urgently to the angiography suite for pelvic angiography. These patients have to tolerate transfer to the suite. Patients receiving primarily angioembolization therapy are defined as the ANGIO group.
Retroperitoneal pelvic packing (PACK)
Indication for pelvic packing is persistent SBP <90 mmHg during the initial resuscitation period with 3000 ml of intravenous (IV) crystalloids and transfusion of 4 PRBC units. These patients are treated primarly with retroperitoneal packing, while angioembolization OR staff is unavailable, and are defined as the PACK group.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
In-hospital mortality
Secondary outcome measures
1. Complications
2. Time from admission to surgery
3. Surgical time
4. Days on ICU
5. Postoperative PRBC units administered
6. Secondary procedures.
Overall trial start date
01/02/2003
Overall trial end date
28/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients admitted with:
1. Multitrauma defined as Injury Severity Score (ISS) > 17
2. Dislocated pelvic fracture type B or C according to Tile on emergency department pelvic radiograph
3. Hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
56
Participant exclusion criteria
1. Patients with monotrauma, or Injury Severity Score (ISS) ≤ 17
2. Age > 65 years
3. Age < 18 years
Recruitment start date
01/02/2003
Recruitment end date
28/02/2013
Locations
Countries of recruitment
China
Trial participating centre
Shandong Provincial Hospital
No. 9677, Jingshi Road
Jinan
Jinan
250021
China
Sponsor information
Organisation
Shandong University (China)
Sponsor details
324
Jingwu Road
Jinan
Shandong
250021
China
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Shandong Provincial Hospital (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Akademiska Sjukhuset
Alternative name(s)
Uppsala University Hospital
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Sweden
Results and Publications
Publication and dissemination plan
The trial results will be published in 2015
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26508436