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Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

Primary Purpose

Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PACKING
ANGIO
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock, Hemorrhagic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • multitrauma defined as Injury Severity Score (ISS) > 17
  • dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph
  • hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC).

Exclusion Criteria:

  • monotrauma, or ISS ≤ 17
  • age > 65 years
  • age < 18 years

Sites / Locations

  • Shandong Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ANGIO

PACKING

Arm Description

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) were taken urgently to the angiography suite for pelvic angiography. These patients had to tolerate transfer to the suite. Patients receiving primarily angioembolization therapy were defined as the ANGIO group.

Indication for pelvic packing was persistent SBP<90 mmHg during the initial resuscitation period with 3000 ml of intravenous (IV) crystalloids and transfusion of 4 PRBC units. These patients were treated primarly with retroperitoneal packing, while angioembolization OR staff was unavailable (5pm-7am), and were defined as the PACK group.

Outcomes

Primary Outcome Measures

Number of participants deceased occurring in-hospital during or after treatment with packing or embolization

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of postoperative packed red blood cell units administered for each participant
Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)
Packing for ANGIO and angioembolization for PACKING.
Time from admission (in minutes) to treatment (PACKING or ANGIO) for each participant
Procedural/surgical time (in minutes) for each participant
Days on ICU for each participant

Full Information

First Posted
August 5, 2015
Last Updated
October 27, 2017
Sponsor
Uppsala University
Collaborators
Shandong Provincial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02535624
Brief Title
Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures
Official Title
Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures - Quasi-randomized Clinical Trial of 56 Hemodynamically Unstable Patients With Injury Severity Score ≥ 33
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Shandong Provincial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to answer whether minimal invasive vessel clotting (angioembolization) or open surgery (retroperitoneal packing) is more effective for pelvic fractures with massive bleeding. Patients admitted at daytime (7am-5pm) are treated with angioembolization while patients admitted at nighttime (5pm to 7am) are treated with open surgery.
Detailed Description
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. Retroperitoneal pelvic packing, on the one hand, is a relatively simple method in controlling pelvic hemorrhage even with limited resources. Since 89% of pelvic fracture hemorrhage originates from venous bleeding, fracture stabilization and compressive hemostasis by packing is a reasonable approach. Angioembolization, on the other hand, has great high effectiveness with regard to bleeding control, but requires an angiography suite and technical staff. Since hemostasis of retroperitoneal venous bleeding often can be achieved by external pelvic fixation, angioembolization is required for the 11% arterial bleedings which are hard to control by packing. Even though many authors see both methods as complements, time is crucial in the multitrauma setting and the severely injured patient does not tolerate multiple interventions well. Until now good predictors for treatment choice are unavailable, and management of hemodynamically unstable pelvic fractures remains a matter of debate. This study was designed to answer following questions: 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANGIO
Arm Type
Active Comparator
Arm Description
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) were taken urgently to the angiography suite for pelvic angiography. These patients had to tolerate transfer to the suite. Patients receiving primarily angioembolization therapy were defined as the ANGIO group.
Arm Title
PACKING
Arm Type
Active Comparator
Arm Description
Indication for pelvic packing was persistent SBP<90 mmHg during the initial resuscitation period with 3000 ml of intravenous (IV) crystalloids and transfusion of 4 PRBC units. These patients were treated primarly with retroperitoneal packing, while angioembolization OR staff was unavailable (5pm-7am), and were defined as the PACK group.
Intervention Type
Procedure
Intervention Name(s)
PACKING
Other Intervention Name(s)
retroperitoneal pelvic packing
Intervention Description
By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding
Intervention Type
Procedure
Intervention Name(s)
ANGIO
Other Intervention Name(s)
angioembolization
Intervention Description
Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.
Primary Outcome Measure Information:
Title
Number of participants deceased occurring in-hospital during or after treatment with packing or embolization
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Number of postoperative packed red blood cell units administered for each participant
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)
Description
Packing for ANGIO and angioembolization for PACKING.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Time from admission (in minutes) to treatment (PACKING or ANGIO) for each participant
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Procedural/surgical time (in minutes) for each participant
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Title
Days on ICU for each participant
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: multitrauma defined as Injury Severity Score (ISS) > 17 dislocated pelvic fracture type B or C according to Tile[10] on emergency department pelvic radiograph hemodynamic instability defined as systolic blood pressure (SBP) <90 mmHg after administration of 4 units of packed red blood cells (PRBC). Exclusion Criteria: monotrauma, or ISS ≤ 17 age > 65 years age < 18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Zhou, MD, PhD
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26508436
Citation
Li Q, Dong J, Yang Y, Wang G, Wang Y, Liu P, Robinson Y, Zhou D. Retroperitoneal packing or angioembolization for haemorrhage control of pelvic fractures--Quasi-randomized clinical trial of 56 haemodynamically unstable patients with Injury Severity Score >/=33. Injury. 2016 Feb;47(2):395-401. doi: 10.1016/j.injury.2015.10.008. Epub 2015 Oct 22.
Results Reference
derived

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Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

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