Condition category
Injury, Occupational Diseases, Poisoning
Date applied
21/07/2015
Date assigned
03/08/2015
Last edited
29/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Dr Yohan Robinson

ORCID ID

Contact details

Uppsala University Hospital
Department of Surgical Sciences
Uppsala
75332
Sweden

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 measures

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

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

http://en.sdu.edu.cn

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26508436

Publication citations

Additional files

Editorial Notes