Shock, HemorrhagicNCT02535624
Retroperitoneal Packing or Angioembolization for Hemorrhage Control of Pelvic Fractures
A study testing PACKING and ANGIO in people with Shock, Hemorrhagic and Fractures, Bone, run by Uppsala University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma
- What is being tested?
- PACKING and ANGIO
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Feb 2003to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- monotrauma, or ISS ≤ 17
- age > 65 years
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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?
- Conditions
- Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma
- Being tested
- PACKING, ANGIO
- Medical subject headings
- Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACKINGProcedure or surgery
Also called retroperitoneal pelvic packing
By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding
ANGIOProcedure or surgery
Also called angioembolization
Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: PACKING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants deceased occurring in-hospital during or after treatment with packing or embolization
Measured: 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
Measured: 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
Measured: 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)
Packing for ANGIO and angioembolization for PACKING.
Measured: 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
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Procedural/surgical time (in minutes) for each participant
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Days on ICU for each participant
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startFeb 2003
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shock, HemorrhagicStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Dongsheng Zhou, MD, PhD, Study director, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535624
- Sponsor's protocol ID
- PELVIC001
- Status last verified
- Oct 2017
- First submitted
- 5 Aug 2015
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26508436
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02535624
- Acronym / sponsor ID
- PELVIC001
- Conditions
- Shock, Hemorrhagic, Fractures, Bone, Multiple Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital
- Study start
- Feb 2003
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANGIO | Active comparator | Procedure: ANGIOPatients 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. |
| PACKING | Active comparator | Procedure: PACKINGIndication 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- monotrauma, or ISS ≤ 17
- age > 65 years
- age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PACKINGAlso: retroperitoneal pelvic packingBy retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding | Procedure or surgery | PACKING |
| ANGIOAlso: angioembolizationUsing en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils. | Procedure or surgery | ANGIO |
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
Days on ICU for each participant
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
- Derived from this study: PubMed 26508436Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dongsheng Zhou, MD, PhD study director
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PACKING and ANGIO in people with Shock, Hemorrhagic and Fractures, Bone, run by Uppsala University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.