Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

Shock, Hemorrhagic Clinical Trial

— PROCOAG  

Official title:

Impact of Early Administration of Prothrombin Concentrate Complex in Patients With Acute Hemorrhage Following Severe Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218722
• Other study ID #: 38RC16.046
• Status: Completed
• Phase: Phase 3
• Start date: December 29, 2017
• Est. completion date: June 15, 2022

Study information

• Verified date: November 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 15, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Hemorrhage
• Shock, Hemorrhagic

Intervention

Drug:
• Pro-Thrombin Concentrate Complex
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.
• NaCl 0.9%
Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.

Locations

Country	Name	City	State
France	Annecy University Hospital	Annecy
France	AP-HP Beaujon	Clichy
France	Grenoble University Hospital	Grenoble
France	AP-HP Kremlin Bicêtre	Le Kremlin-Bicêtre
France	Lille University Hospital	Lille
France	HCL - Hôpital Edouard Herriot	Lyon
France	AP-HM - Marseille Nord	Marseille
France	Montpellier University Hospital	Montpellier
France	Nantes University Hospital	Nantes
France	AP-HP Pitié Salpetrière	Paris
France	HCL - Lyon Sud	Pierre-Bénite
France	Strasbourg University Hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Labile blood products transfused in the first 24 hours	This outcome is measured in number of bags administered	24 hours following hospital admission
Secondary	RBC (Red Blood Cells) transfused in the first 24 hours	This outcome is measured in number of bags administered	24 hours following hospital admission
Secondary	FFP transfused in the first 24 hours	This outcome is measured in number of bags administered	24 hours following hospital admission
Secondary	Platelets transfused in the first 24 hours	This outcome is measured in number of bags administered	24 hours following hospital admission
Secondary	Time to achieve Prothrombin ratio < 1.5		Within the first 24 hours
Secondary	Time to hemostasis	Hemostasis is defined as bleeding control in the surgical field or resolution of contrast blush after embolization during interventional radiology	Within the first 24 hours following admission
Secondary	Thrombo-embolic events		ICU stay (an average of 28 days)
Secondary	Mortality		24 hours and Day 28
Secondary	ICU-free days	Number of in-hospital days outside Intensive Care Unit (ICU)	Hospital stay (an average of 28 days)
Secondary	Ventilator-Free Days	Number of days without mechanical ventilation	ICU stay (an average of 21 days)
Secondary	Hospital-free days	Number of days outside hospital	Within the first 28 days
Secondary	Glasgow Outcome Scale Extended (GOSE)		Day 28
Secondary	Hospitalisation status		Day 28
Secondary	Cost of the strategy		Day 8 and Day 28