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Hemorrhagic ShockNCT07695129

Hemorrhagic Shock in Orthopedic Fractures

An observational study of Hemorrhagic Shock and Pelvic Fractures, run by Sohag University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
250 participants
Where
1 siteEgypt
Study dates
25 Jul 2026to 10 Jan 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: patients with long bone or\and pelvic fractures presenting to the emergency department of sohag university hospital

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yahia Z Elsayed, Emergency Medicine resident contact

+20 01158658683

Yehia.Hafez@med.sohag.edu.eg

Mohamed Y Mohamed, MD in orthopedic sugery contact

+20 01028900884

mohamedyounis888@hotmail.com

Egypt1 site
  • Sohag University

    Sohag

    sohag university, +20 01002552419, ethics@med.sohag.edu.eg

Other trials in Egypt

About this study

Official title: 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

Read the 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 .

Medical subject headings
Shock, Hemorrhagic, Hip Fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hemorrhagic shock

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

    Measured: 1 hour ,2 hours , 4 hours and 6 hours

Secondary outcomes (1)
  1. Blood transfusion requirements

    Measured: 1st hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start25 Jul 2026 (estimated)
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion10 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07695129
Sponsor's protocol ID
Soh-Med-26-6-7MS
Status last verified
Jul 2026
First submitted
5 Jul 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hemorrhagic Shock and Pelvic Fractures, run by Sohag University at 1 site in Egypt.

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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 10 Jul 2026. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yahia Z Elsayed, Emergency Medicine resident (+20 01158658683, Yehia.Hafez@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hemorrhagic shock (time frame: 1 hour ,2 hours , 4 hours and 6 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 Jul 2026.

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