Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures

NCT02535624 | Completed

• 1 other identifier: PELVIC001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock, Hemorrhagic; Fractures, Bone; Multiple Trauma

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (6)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

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

• Number of postoperative packed red blood cell units administered for each participant

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

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

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

• Time from admission (in minutes) to treatment (PACKING or ANGIO) for each participant

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

• Procedural/surgical time (in minutes) for each participant

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

Study Arms (2)

ANGIO

ACTIVE COMPARATOR

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.

Procedure: ANGIO

PACKING

ACTIVE COMPARATOR

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.

Procedure: PACKING

Interventions

PACKING PROCEDURE

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

Also known as: retroperitoneal pelvic packing

PACKING

ANGIO PROCEDURE

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

Also known as: angioembolization

ANGIO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Related Publications (1)

• 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.

  PMID: 26508436 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Fractures, Bone; Multiple Trauma

Interventions

Drug Packaging

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Drug Industry; Manufacturing Industry; Industry; Technology, Industry, and Agriculture; Product Packaging

Study Officials

• Dongsheng Zhou, MD, PhD

  Shandong Provincial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: August 28, 2015
• Study Start: February 1, 2003
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

CN (1)