ClinicalTrials.gg
Not yet recruitingNCT07695129Updated Jul 10, 2026

Hemorrhagic Shock in Orthopedic Fractures

An observational study in Hemorrhagic Shock, Pelvic Fractures and Long Bone Fractures, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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 .

02

Conditions studied

  • Hemorrhagic Shock
  • Pelvic Fractures
  • Long Bone Fractures
03

In context

Shock, Hemorrhagic

79 studies on the registry are indexed under Shock, Hemorrhagic; 15 are open to participants now.

This study's planned enrollment of 250 is above the median of 113 across 30 observational studies indexed under Shock, Hemorrhagic.

Browse Shock, Hemorrhagic studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Incidence of hemorrhagic shock

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

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

Secondary outcomes

  1. Blood transfusion requirements

    Time frame: 1st hour

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07695129
Lead sponsor
Sohag University
Responsible party
Yehia Zakaria Elsayed (Resident, Sohag University) — Principal investigator
First posted
Jul 10, 2026
Start date
Jul 25, 2026 (estimated)
Primary completion
Dec 25, 2026 (estimated)
Completion
Jan 10, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Yahia Z Elsayed, Emergency Medicine resident
Contact
Yehia.Hafez@med.sohag.edu.eg
+20 01158658683
Mohamed Y Mohamed, MD in orthopedic sugery
Contact
mohamedyounis888@hotmail.com
+20 01028900884
Yahia Z Elsayed, Emergency Medicine resident
principal investigator · Sohag University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion