OC 51.2 - Systematic immediate Vitamin K antagonist reversal with prothrombin complex concentrate in patients with recent mild traumatic brain injury (PREVACT): a multicenter, randomized, controlled trial.

Tuesday, June 27, 2023

11:00 – 11:15 ET

Room: 710A

Session Available As: On-Demand

Presenting Author(s)

Pierre-Marie Roy, MD, PhD (he/him/his)

MD, PhD
Service des urgences, Centre Hospitalo-Universitaire d’Angers, Institut MITOVASC, EA 3860, Université d'Angers, Angers, FCRIN INNOVTE, France.
Angers, Pays de la Loire, France

Co-Author(s)

DD

Delphine Douillet

MD, PhD
Emergency Department, CHU Angers
Angers, Pays de la Loire, France
ED

Emilie Dehours

MD
Emergency Department, CHU Toulouse, Toulouse, France.
Toulouse, Midi-Pyrenees, France
CB

Christian Brice

MD
Emergency Department, Centre Hospitalier de Saint-Brieuc, Saint-Brieuc, France.
Saint-Brieuc, Bretagne, France
HA

Hery Andrianjafy

MD
Emergency Department, Centre Hospitalier de Longjumeau, Longjumeau, France
Longjumeau, Ile-de-France, France
AT

Albert Trinh-Duc

MD
Emergency Department, Centre Hospitalier d’Agen, Agen, France.
Agen, Midi-Pyrenees, France
SP

Sabrina Perlet

MD
Emergency Department, Centre Hospitalier de Saint-Malo, Saint-Malo, France.
Saint-Malo, Bretagne, France
BD

Bertrand Drugeon

MD
Emergency Department, CHU Poitiers, Poitiers, France.
Poitiers, Centre, France
NB

Nicolas Bournaud

MD
Emergency Department, Centre Hospitalier de Montauban, Montauban, France.
Montauban, Midi-Pyrenees, France
ES

Elisabeth Saligari

MD
Emergency Department, Centre Hospitalier d’Annecy, Annecy, France.
Annecy, Rhone-Alpes, France
JL

Jacques Levraut

MD, PhD
Emergency Department, CHU Nice, Université de Nice, Nice, France.
Nice, Provence-Alpes-Cote d'Azur, France
SD

Sandrine Dautheville

MD
Emergency Department, Hôpital Tenon, APHP, Paris, France.
Paris, Ile-de-France, France
MG

Mahjoub Gabteni

MD
Emergency Department, CHU Bretonneau, Tours, France.
Tours, Centre, France
SL

Sigismond Lasocki

MD, PhD
Department of Anesthesia and Intensive Care, CHU Angers, Angers, France
Angers, Pays de la Loire, France
FP

Fabrice Prunier

MD, PhD
Department of Cardiology, CHU Angers, Angers, France
Angers, Pays de la Loire, France
ML

Matthieu Labriffe

MD
Radiology Department, CHU Angers, UNIV Angers, Angers, France
Angers, Pays de la Loire, France
LJ

Luc-Marie Joly

MD, PhD
Emergency Department, CHU Rouen, Rouen, France
Rouen, Haute-Normandie, France
PJ

Patricia Jabre

MD, PhD
SAMU de Paris, Hôpital Necker, APHP, Paris, France.
Paris, Ile-de-France, France
JR

Jérémie Riou

PhD
Methodology and Biostatistics Department, Delegation to Clinical Research and Innovation, CHU Angers, Angers, France
Angers, Pays de la Loire, France
KT

Karim Tazarourte

MD, PhD
Emergency Department, Centre Hospitalier Universitaire Édouard Herriot, Hospices Civils de Lyon, Lyon, France
Lyon, Rhone-Alpes, France

Background: Trauma brain injury (TBI) in patients receiving vitamin K antagonist (VKA) is associated with a high rate of intracranial hemorrhage (ICH) and subsequent functional impairment.

Aims: To assess the efficacy of prompt systematic reversal of anticoagulation with 4-factor prothrombin complex concentrate (PCC) in patients presenting to Emergency Department for recent isolated mild TBI while receiving VKA for atrial fibrillation.

Methods: Open-label with blinded endpoint clinical trial. We planned to randomized 400 patients to systematic immediate VKA reversal with 25 UI/kg of PCC before any investigation (intervention group) or usual care meaning reversal only in case of intracranial bleeding on the initial cranial CT-scan performed as soon as possible (control group) in 21 hospitals. The primary outcome was the rate of ICH on a cranial CT-scan performed 24 hours after inclusion.

Results: The study was prematurely stopped for logistical reasons after the inclusion of 203 patients, 98 were evaluable in the intervention group and 99 in the control group (table). On the H24 cranial CT-scan, 6/98 patients (6.1%) in the intervention group had intracranial bleeding versus 12/99 patients (12.1%) in the control group (odds ratio: 0.48 [95% confidence interval 0.14-1.44]). As compared to the initial CT-scan, the rate of ICH onset or extension was 1/98 (1.1%) in the intervention group versus 5/99 (5.1%) in the control group. Three patients (3.1%) in the intervention group had a thromboembolic event within the 30 days following inclusion and none in the control group. Patients’ functional outcomes are mentioned in the figure.

Conclusion(s): In patients with recent mild TBI and receiving VKA, prompt and systematic reversal with PCC did not significantly reduce the rate of ICH at 24 hours. However, the study was prematurely stopped and does not exclude a clinically important benefit
(ClinicalTrials.gov Identifier: NCT01961804; funded by the French Health Government; approved by the CPP-Ouest-2 ethics committee).

Learning Objectives:

Upon completion, participants will be able to estimate the risk of intracranial hemorrhage in patients with recent mild trauma brain injury while receiving VKA.
Upon completion, participants will be able to criticize current practices meaning reversal of anticoagulation only in case of intracranial bleeding on the initial cranial CT-scan.
Upon completion, participants will be able to discuss the possible clinical benefit of prompt and systematic reversal of anticoagulation without waiting any investigation.