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NCT Number: NCT07695129

Hemorrhagic Shock in Orthopedic Fractures

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Incidence of hemorrhagic shock

    Time frame: 1 hour ,2 hours , 4 hours and 6 hours

    Shock index ≥ .9 Systolic blood pressure measurement < 90mmHg

Secondary outcomes

  1. Blood transfusion requirements

    Time frame: 1st hour

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Y Mohamed, MD in orthopedic sugery

CONTACT

[email protected]

+20 01028900884

Yahia Z Elsayed, Emergency Medicine resident

CONTACT

[email protected]

+20 01158658683

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Incidence and Predictors of Hemorrhagic Shock in Patients With Long Bone Fractures Presenting to the Emergency Department

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

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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