Coagulopathy, Hemorrhage
Conditions
Brief summary
Uncontrolled hemorrhage continues to be a significant source of mortality for trauma patients. Their condition is further complicated by Trauma Induced Coagulopathy (TIC), which makes it more difficult to control bleeding due to coagulation factor deficiency. Prothrombin Complex Concentrate (PCC) is thought to be a promising treatment option. This phase II clinical trial evaluates the use of 4-Factor PCC in addition to standard resuscitation methods compared to standard resuscitation methods alone in patients with TIC. Patients will be randomized at a 1:1 ratio. The primary endpoint of this trial will be 30 day mortality.
Interventions
BIOLOGICALProthrombin Complex Concentrate
single dose of 25 IU/kg of 4-PCC at time of enrollment
BIOLOGICALWhole Blood, Plasma, Packed Red Blood Cells
site's standard resuscitation protocol
Sponsors
Bellal A. Joseph, MD, FACS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥15 years old 2. anticipate giving 4+ units based on Revised Assessment of Bleeding and Transfusion score ≥ 2
Exclusion criteria
1. Cardiopulmonary Resuscitation \> 5 minutes 2. Penetrating cranial injury or exposed brain matter 3. Anticoagulation treatment 4. Transfer patients 5. Known pregnancy 6. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Mortality | 24 hours after enrollment | Assess if patient is alive at 24 hours post treatment |
Contacts
Primary ContactAndrea Seach, BS
Outcome results
None listed