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Completed

NCT Number: NCT03218722

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

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.

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Key information

Conditions

Shock, Hemorrhagic Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Annecy University Hospital, Annecy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Pro-Thrombin Concentrate Complex

Drug

Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.

Other names: KANOKAD

NaCl 0.9%

Drug

Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.

Primary outcomes

  1. Labile blood products transfused in the first 24 hours

    Time frame: 24 hours following hospital admission

    This outcome is measured in number of bags administered

Secondary outcomes

  1. RBC (Red Blood Cells) transfused in the first 24 hours

    Time frame: 24 hours following hospital admission

    This outcome is measured in number of bags administered

  2. FFP transfused in the first 24 hours

    Time frame: 24 hours following hospital admission

    This outcome is measured in number of bags administered

  3. Platelets transfused in the first 24 hours

    Time frame: 24 hours following hospital admission

    This outcome is measured in number of bags administered

  4. Time to achieve Prothrombin ratio < 1.5

    Time frame: Within the first 24 hours

  5. Time to hemostasis

    Time frame: 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

  6. Thrombo-embolic events

    Time frame: ICU stay (an average of 28 days)

  7. Mortality

    Time frame: 24 hours and Day 28

  8. ICU-free days

    Time frame: Hospital stay (an average of 28 days)

    Number of in-hospital days outside Intensive Care Unit (ICU)

  9. Ventilator-Free Days

    Time frame: ICU stay (an average of 21 days)

    Number of days without mechanical ventilation

  10. Hospital-free days

    Time frame: Within the first 28 days

    Number of days outside hospital

  11. Glasgow Outcome Scale Extended (GOSE)

    Time frame: Day 28

  12. Hospitalisation status

    Time frame: Day 28

  13. Cost of the strategy

    Time frame: Day 8 and Day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: PROCOAG

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Jul 14, 2017
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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