- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07695129
Hemorrhagic Shock in Orthopedic Fractures
Incidence and Predictors of Hemorrhagic Shock in Patients With Long Bone Fractures Presenting to the Emergency Department
The goal of this observational study is to learn about the incidence and predators of hemorrhagic shock in patients with Long bone and pelvic fractures .The main question it aims to answer is:
In which bone fracture the prediction and detection of hemorrhagic shock should be in consideration for emergency management in polytrauma patients
Study Overview
Status
Conditions
Detailed Description
Trauma remains a leading cause of mortality worldwide, particularly among young adults, with hemorrhage accounting for a significant proportion of early preventable deaths . Hemorrhagic shock is a form of hypovolemic shock resulting from acute blood loss leading to inadequate tissue perfusion and oxygen delivery to meet cellular metabolic demands.
hemorrhagic shock occurs when systolic blood pressure (SBP) < 90 mmHg , Shock index ≥ 0.9 , serum lactate level ≥ 2 mmol/L or need for massive transfusion .
hemorrhagic shock is a critical complication of traumatic injuries associated with high morbidity and mortality if not promptly recognized and managed. Among traumatic injuries, fractures of long bones and the pelvis are particularly important due to their potential for substantial internal blood loss.
The Shock Index is calculated as:
Shock Index (SI) = Heart Rate (HR) ÷ Systolic Blood Pressure (SBP) Normal SI: 0.5 - 0.7 Early concern SI: ≥ 0.9 Indicative of hemorrhagic shock SI ≥ 1.0 . Long bone fractures, especially femoral fractures, can result in significant hemorrhage due to disruption of intramedullary vessels and surrounding soft tissues [4]. When multiple long bones are involved, the cumulative blood loss may be considerable and can contribute to the development of hypovolemic shock. Pelvic fractures, however, are even more concerning, as they are often associated with high-energy trauma and complex vascular injuries. The pelvis contains extensive venous plexuses and major arterial branches, making it a major source of life-threatening hemorrhage. It is estimated that venous bleeding accounts for approximately 80% of hemorrhage in pelvic fractures, primarily from the presacral and prevesical venous plexuses .
Patients with pelvic fractures frequently present with hemodynamic instability and may rapidly deteriorate into hemorrhagic shock. These injuries are associated with significant mortality, particularly when shock is present. Studies have shown that pelvic fractures complicated by hemorrhagic shock carry mortality rates of up to 30%, highlighting their severity and the need for early recognition and intervention . Furthermore, pelvic injuries are strongly associated with trauma-induced coagulopathy, which further exacerbates bleeding and worsens outcomes .
Early identification of patients at risk of hemorrhagic shock is crucial in the emergency department (ED) setting. Several clinical and laboratory parameters have been investigated as potential predictors. Variables such as shock index, lactate level, base deficit, and Glasgow Coma Scale (GCS) have been shown to correlate with severity and outcomes in trauma patients . In patients with pelvic fractures, factors such as elevated lactate, hypothermia, and unstable fracture patterns (e.g., type B and C injuries) have been identified as predictors of significant hemorrhage and the need for intervention . Additionally, parameters including shock index, mean arterial pressure, lactate, and fibrinogen levels have demonstrated strong predictive value for mortality in patients with pelvic fractures complicated by shock .
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yahia Z Elsayed, Emergency Medicine resident
- Phone Number: +20 01158658683
- Email: Yehia.Hafez@med.sohag.edu.eg
Study Contact Backup
- Name: Mohamed Y Mohamed, MD in orthopedic sugery
- Phone Number: +20 01028900884
- Email: mohamedyounis888@hotmail.com
Study Locations
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Sohag, Egypt
- Sohag University
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Contact:
- sohag university
- Phone Number: +20 01002552419
- Email: ethics@med.sohag.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged between 18 and 65 years
Presentation with radiologically confirmed:
- Long bone fractures (femur, tibia, fibula, humerus, radius, ulna) and/or
- Pelvic fractures
- Presentation within 24 hours of injury
Exclusion Criteria:
- Penetrating trauma to the abdomen and/or the chest.
- Known bleeding disorders.
- Patients on anticoagulants.
- Major external hemorrhage requiring immediate surgical control
- Isolated minor fractures (e.g., bones of hands or feet).
- Dead on arrival
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of hemorrhagic shock
Time Frame: 1 hour ,2 hours , 4 hours and 6 hours
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Shock index ≥ .9
Systolic blood pressure measurement < 90mmHg
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1 hour ,2 hours , 4 hours and 6 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood transfusion requirements
Time Frame: 1st hour
|
1st hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yahia Z Elsayed, Emergency Medicine resident, Sohag University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-6-7MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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