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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04764864
Other study ID # PELVITRAU
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date January 1, 2022

Study information

Verified date January 2022
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pelvic fracture is a usual injury in trauma patients. An unstable trauma patient with a pelvic fracture has an elevated risk of death due to pelvic bleeding and the associated injuries. Traditionally, it has been estimated that the main source of bleeding is venous and, consequently, the main treatment has been the preperitoneal pelvic packing. Nevertheless, according to new data, arterial bleeding appears to be a more important source of pelvic bleeding than it was thought and angioembolization seems to be a good alternative in the treatment of these injuries. Consequently, it is important to define better the management of these patients. This investigation project consists in a clinical trial study, performed by a multidisciplinary team of many hospitals around the country, in which angioembolization and preperitoneal pelvic packing are compared. Unstable trauma patients with a pelvic fracture and no other injuries (negative FAST / peritoneal aspiration, no evidence of bone fractures or thoracic injuries) will be submitted, in less than 60 minutes from hospital arrival, to angioembolization or preperitoneal pelvic packing, according to randomization. There will be a specific timing evaluation of different markers: hemodynamic (vital signs at arrival, immediately and 24 hours after treatment) and analytic (at arrival and upon entering to the Intensive Care Unit). Registered variables include: blood cell transfusions, vasoactive drug requirements, time elapsed between hospital admission and intervention, treatment duration, need of other strategies to stop pelvic bleeding, complications and mortality. The objective of this study is to determinate if angioembolization is superior to preperitoneal pelvic packing for pelvic bleeding control in unstable trauma patients due to pelvic bleeding.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Systolic blood pressure = 90 mmHg - Heart rate > 100 bpm - Shock Index = 0,8 - Pelvic fracture - Negative FAST / peritoneal aspiration Exclusion Criteria: - Other causes of bleeding that require treatment

Study Design


Intervention

Procedure:
Angioembolization
Via the femoral route, a non-selective pelvic arteriography with a selective embolization of the arterial branches that show direct or indirect signs of injury will be performed. In the event of persistent hemodynamic instability after selective embolization, non-selective bilateral embolization of the internal iliac arteries will be evaluated. The material used will vary depending on the characteristics of the injury and the availability of the materials.
Preperitoneal Pelvic Packing
Pfannestiel incision / infraumbilical laparotomy. Dissection of tissues up to and including the transversalis fascia. Inferior to this and anterior to the peritoneum, the preperitoneal cavity is identified. Inclusion of radiopaque laparotomy gauze in each hemipelvis, from the posterior part (anterior to the sacro-iliac joint) to the most anterior in the retropubic position. Subsequently, the closure is carried out to increase the plugging effect. A second intervention is required to remove the material in 24-48 hours.

Locations

Country Name City State
Spain Corporació Sanitària Parc Taulí Sabadell Barcelona

Sponsors (2)

Lead Sponsor Collaborator
Nuria Llorach-Perucho Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Time until arrival at hospital Time elapsed between prehospital attention and hospital admission Time until arrival at hospital (up to 30 minutes)
Other Duration of angioembolization Duration of angioembolization Through study completion, an average of 2 years
Other Angioembolization treatment Arteries treated with angioembolization Through study completion, an average of 2 years
Other Duration of Preperitoneal Pelvic Packing Duration of Preperitoneal Pelvic Packing Through study completion, an average of 2 years
Other Intensive care unit stay Number of days that the patient remains in the intensive care unit Through study completion, an average of 2 years
Other Hospital stay Number of days that the patient remains in hospital Through study completion, an average of 2 years
Other Readmission Readmission 30 days after discharge 30 days after discharge
Primary Pelvic bleeding control based on clinical response Clinical response after the intervention 24 hours
Secondary Additional techniques Need for additional techniques after the intervention to control bleeding associated with pelvic fracture Through study completion, an average of 2 years
Secondary Post-procedure complications Presence of post-procedure complications Through study completion, an average of 2 years
Secondary Post-procedure complications degree Description of post-procedure complications: Clavien Dindo scale Through study completion, an average of 2 years
Secondary Post-procedure complications degree Description of post-procedure complications: Comprehensive Complication Index Through study completion, an average of 2 years
Secondary Mortality Death of the pacient (cause and date) Through study completion, an average of 2 years
Secondary Blood cell transfusion Need for blood cell transfusion for patients (number and need for masive transfusion protocol activation) Through study completion, an average of 2 years
Secondary Time until intervention Time elapsed between hospital admission and intervention Time until intervention (up to 60 minutes)
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