Shock, Hemorrhagic
Conditions
Keywords
Acute traumatic coagulopathy, Hemostasis, Severe hemorrhage
Brief summary
Acute traumatic coagulopathy (ATC) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. ATC is associated with fibrinogen and clotting factors deficiencies. Therefore, ATC management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between Fresh Frozen Plasma (FFP) and Red Blood Cells (RBC). This strategy relies on fast supply of FFP. To overcome delay for FFP ordering, transport and defrosting, the PROCOAG study proposes to use prothrombrin concentrate complex (PCC) as alternative to treat coagulation factor deficiency. PCC is readily available upon hospital arrival. In addition to fibrinogen treatment, it is thought that PCC can be efficient in ATC management, while reducing risks associated with massive transfusion. ProCoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early PPC+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion. Early administration of PPC should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.
Interventions
DRUGPro-Thrombin Concentrate Complex
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.
DRUGNaCl 0.9%
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Primary admission for a severe trauma * Out-of-hospital transfusion or RBC transfusion within the first hour following hospital admission * Clinical prediction or ABC score (Assessment of Blood Consumption) ≥ 2 of massive transfusion defined by a transfusion of at least 10 CGR during the first 24 hours or 3 CGR during the first hour. * Informed consent signed by a relative or emergency procedure
Exclusion criteria
* Cardiac arrest before randomisation * Secondary transfer from another hospital (a technical stop is accepted) * Post-traumatic lesions out of therapeutic resources with death expected in the hour following hospital admission * Anti-coagulation treatment (K anti-vitamine, new oral anticoagulant) * Pregnancy * Hypersensitivity to active substances or one of the excipients of KANOKAD® * Patient treated with an experimental medicine within the last 30 days * Decision of therapeutic limitation before randomisation * Patient protected by article L1121-7 of the French Public health code. * Knowledge of a contraindication to the use of NaCl 0.9% at the dose of 1 mg/kg (hyperchloremia, hypernatremia...)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Labile blood products transfused in the first 24 hours | 24 hours following hospital admission | This outcome is measured in number of bags administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FFP transfused in the first 24 hours | 24 hours following hospital admission | This outcome is measured in number of bags administered |
| Platelets transfused in the first 24 hours | 24 hours following hospital admission | This outcome is measured in number of bags administered |
| Time to achieve Prothrombin ratio < 1.5 | Within the first 24 hours | — |
| Time to hemostasis | Within the first 24 hours following admission | Hemostasis is defined as bleeding control in the surgical field or resolution of contrast blush after embolization during interventional radiology |
| Thrombo-embolic events | ICU stay (an average of 28 days) | — |
| Mortality | 24 hours and Day 28 | — |
| RBC (Red Blood Cells) transfused in the first 24 hours | 24 hours following hospital admission | This outcome is measured in number of bags administered |
| Ventilator-Free Days | ICU stay (an average of 21 days) | Number of days without mechanical ventilation |
| Hospital-free days | Within the first 28 days | Number of days outside hospital |
| Glasgow Outcome Scale Extended (GOSE) | Day 28 | — |
| Hospitalisation status | Day 28 | — |
| Cost of the strategy | Day 8 and Day 28 | — |
| ICU-free days | Hospital stay (an average of 28 days) | Number of in-hospital days outside Intensive Care Unit (ICU) |
Countries
France
Outcome results
None listed