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Completed

NCT Number: NCT02535624

Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Packing

Procedure

By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding

Other names: retroperitoneal pelvic packing

ANGIO

Procedure

Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.

Other names: angioembolization

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Number of participants which required a secondary procedure (PACKING or ANGIO) after the primary intervention (PACKING or ANGIO)

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks

    Packing for ANGIO and angioembolization for PACKING.

  4. 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

  5. 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

  6. Days on ICU for each participant

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Shandong Provincial Hospital

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Aug 28, 2015
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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