- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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 .
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yahia Z Elsayed, Emergency Medicine resident
- Numéro de téléphone: +20 01158658683
- E-mail: Yehia.Hafez@med.sohag.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Mohamed Y Mohamed, MD in orthopedic sugery
- Numéro de téléphone: +20 01028900884
- E-mail: mohamedyounis888@hotmail.com
Lieux d'étude
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Sohag, Egypte
- Sohag University
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Contact:
- sohag university
- Numéro de téléphone: +20 01002552419
- E-mail: ethics@med.sohag.edu.eg
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of hemorrhagic shock
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Blood transfusion requirements
Délai: 1st hour
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1st hour
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yahia Z Elsayed, Emergency Medicine resident, Sohag University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Soh-Med-26-6-7MS
Plan pour les données individuelles des participants (IPD)
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