Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04745520
Eligibility Criteria:
Inclusion Criteria:
* At least 2 rib fractures
* At least 1 dislocated rib fracture
* Fractures accessible to surgery
* Thoracic trauma no more than two days prior to screening for inclusion
* Thoracic epidural analgesia
* Written informed consent
Exclusion Criteria:
* Any other concomitant fractures excepted clavicle fracture
* Respiratory distress syndrome according to the Berlin definition
* Presence of \>1.5 liter of blood drained from the pleural space
* Hemostasis disorder defined by any of the following criteria:
* Platelet count \< 70'000/mm3,
* International Normalized Ratio (INR) \> 1.2 (Prothrombin \< 70%)
* activated partial thromboplastin time (aPTT) ≥ 60 seconds
* drugs such as: P2Y12 antagonists (clopidogrel, prasugrel) and glycoprotein IIb/IIIa antagonists (abciximab, tirofiban)
* Pathological rib fracture due to metastasis
* Hemodynamic instability: systolic blood pressure \< 100 mmHg and heart rate \> 100 beats per minute
* Neurologic disorder: Glasgow Coma Score \< 13 in the initial 24 hours, or intracerebral, epidural, subdural, or subarachnoid hemorrhages, or cerebral contusion
* Titanium allergy
* Known or suspected non-compliance to medical therapy due to drug or alcohol abuse
* Age \<18 years old
* Women who know they are pregnant or breast feeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04745520
Study Brief:
Protocol Section:
NCT04745520