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Clinical Trial Results:
Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger

Summary
EudraCT number	2013-000421-31
Trial protocol	FR
Global end of trial date	03 Sep 2020

Results information
Results version number	v1(current)
This version publication date	07 Jan 2024
First version publication date	07 Jan 2024
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

PHRC2012-02

ISRCTN number

US NCT number

NCT01961804

WHO universal trial number (UTN)

Sponsor organisation name

CHU Angers

Sponsor organisation address

4 Rue Larrey, ANGERS, France,

Public contact

Direction de la Recherche, CHU d'Angers, +33 0241356825, begable@chu-angers.fr

Scientific contact

Direction de la Recherche, CHU d'Angers, +33 0241356825, begable@chu-angers.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

12 Dec 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Feb 2020

Global end of trial reached?

Yes

Global end of trial date

03 Sep 2020

Was the trial ended prematurely?

Main objective of the trial

Démontrer que la réalisation d’une réversion systématique préventive des patients traumatisés crâniens légers (CGS de 13 à 15), permet une diminution significative des hémorragies intracrâniennes comparativement à une réversion réalisée qu’après constatation d’une hémorragie post-traumatique sur une imagerie cérébrale.

Protection of trial subjects

no specific protection, patient with suspected intracranial bleeding

Background therapy

Evidence for comparator

Actual start date of recruitment

07 Mar 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 202

Worldwide total number of subjects

202

EEA total number of subjects

202

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

151

Subject disposition

Top of page

Recruitment details

patients admitted in the emergency department for head trauma under VKA treatment

Screening details

VKA treatment

Period 1 title

Study period (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Control

Arm description

Routine care

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Interventionnal

Arm description

Kanokad before CT-Scan

Arm type

Experimental

Investigational medicinal product name

KANOKAD

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

25UI/kg

Number of subjects in period 1	Control	Interventionnal
Started	101	101
Completed	99	98
Not completed	2	3
Consent withdrawn by subject	-	2
Protocol deviation	2	1

Baseline characteristics

Top of page

Reporting group title

Control

Reporting group description

Routine care

Reporting group title

Interventionnal

Reporting group description

Kanokad before CT-Scan

Reporting group values	Control	Interventionnal	Total
Number of subjects	101	101	202
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	1	1	2
From 65-84 years	22	27	49
85 years and over	78	73	151
Age continuous
Units: years
arithmetic mean (standard deviation)	91 ( 7.9 )	90 ( 8.2 )	-
Gender categorical
Units: Subjects
male	46	52	98
female	55	49	104

Subject analysis set title

Control arm

Subject analysis set type

Intention-to-treat

Subject analysis set description

Groups don't show significant differences in the characteristics of inclusion or compliance with the assigned intervention and other aspects of managing

Subject analysis set title

Interventional arm

Subject analysis set type

Intention-to-treat

Subject analysis set description

Groups don't show significant differences in the characteristics of inclusion or compliance with the assigned intervention and other aspects of managing

Subject analysis sets values	Control arm	Interventional arm
Number of subjects	99	98
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	1	1
From 65-84 years	26	22
85 years and over	71	76
Age continuous
Units: years
arithmetic mean (standard deviation)	90 ( 8.2 )	91 ( 7.9 )
Gender categorical
Units: Subjects
male	51	44
female	47	55

End points

Top of page

Reporting group title

Control

Reporting group description

Routine care

Reporting group title

Interventionnal

Reporting group description

Kanokad before CT-Scan

Subject analysis set title

Control arm

Subject analysis set type

Intention-to-treat

Subject analysis set description

Groups don't show significant differences in the characteristics of inclusion or compliance with the assigned intervention and other aspects of managing

Subject analysis set title

Interventional arm

Subject analysis set type

Intention-to-treat

Subject analysis set description

Groups don't show significant differences in the characteristics of inclusion or compliance with the assigned intervention and other aspects of managing

Primary: intracranial hemorrhage

Top of page

End point title

intracranial hemorrhage

End point description

End point type

Primary

End point timeframe

between +20h and +28h after inclusion

End point values	Control	Interventionnal	Control arm	Interventional arm
Number of subjects analysed	99	98	99	98
Units: individual	99	98	99	98

statistical analysis

Comparison groups

Control arm v Interventional arm

Number of subjects included in analysis

197

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.215

Method

Fisher exact

Parameter type

Odds ratio (OR)

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

0.14

upper limit

1.44

Variability estimate

Standard deviation

Adverse events

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Timeframe for reporting adverse events

7 March 2014 to 7 September 2020

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

8.1

Reporting group title

Control

Reporting group description

Reporting group title

Kanokad

Reporting group description

Serious adverse events	Control	Kanokad
Total subjects affected by serious adverse events
subjects affected / exposed	36 / 101 (35.64%)	28 / 98 (28.57%)
number of deaths (all causes)	24	13
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Haematoma
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematoma muscle
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemothorax
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	2 / 101 (1.98%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 2	1 / 1
deaths causally related to treatment / all	0 / 0	1 / 1
Myocardial infarction
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Peripheral ischaemia
subjects affected / exposed	0 / 101 (0.00%)	2 / 98 (2.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Shock haemorrhagic
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 101 (0.99%)	2 / 98 (2.04%)
occurrences causally related to treatment / all	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Wound haematoma
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Death
subjects affected / exposed	2 / 101 (1.98%)	2 / 98 (2.04%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 2
Multiple organ dysfunction syndrome
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Oedema peripheral
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchopneumopathy
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Lung disorder
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia aspiration
subjects affected / exposed	3 / 101 (2.97%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory distress
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
Craniocerebral injury
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fall
subjects affected / exposed	4 / 101 (3.96%)	4 / 98 (4.08%)
occurrences causally related to treatment / all	0 / 4	0 / 4
deaths causally related to treatment / all	0 / 0	0 / 0
Femoral neck fracture
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Head injury
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hip fracture
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Bradyarrhythmia
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac arrest
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	4 / 101 (3.96%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardio-respiratory arrest
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Right ventricular failure
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
Altered state of consciousness
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebellar syndrome
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epilepsy
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Neurological decompensation
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Seizure
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin haemorrhage
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 101 (0.00%)	2 / 98 (2.04%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bone lesion
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Epiglottitis
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Control	Kanokad
Total subjects affected by non serious adverse events
subjects affected / exposed	12 / 101 (11.88%)	7 / 98 (7.14%)
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences all number	0	1
Vascular disorders
epistaxis
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences all number	1	1
Haematoma
subjects affected / exposed	2 / 101 (1.98%)	0 / 98 (0.00%)
occurrences all number	2	0
Soft tissue haemorrhage
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0
Pain
subjects affected / exposed	2 / 101 (1.98%)	0 / 98 (0.00%)
occurrences all number	2	0
Cardiac disorders
Cardiac failure
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences all number	0	1
Nervous system disorders
Neurological examination abnormal
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0
Myositis
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences all number	0	1
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
Discomfort
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0
Infections and infestations
Urinary tract infection bacterial
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences all number	0	1
Urinary tract infection
subjects affected / exposed	0 / 101 (0.00%)	1 / 98 (1.02%)
occurrences all number	0	1
Urinary retention
subjects affected / exposed	1 / 101 (0.99%)	1 / 98 (1.02%)
occurrences all number	1	1
Bronchitis
subjects affected / exposed	1 / 101 (0.99%)	0 / 98 (0.00%)
occurrences all number	1	0

More information

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Were there any global substantial amendments to the protocol? Yes

20 Dec 2013

addition of ANSM requests and clarification on randomization

21 Jul 2014

primary outcome deadline updated

17 Jul 2015

Inclusion and non-inclusion criteria updated

25 Sep 2015

Updated list of associated centers and modified consent formatting

02 Feb 2016

extended inclusion period

26 Apr 2016

New study site

20 Sep 2016

Update of investigator centers (opening and closing), change of principal investigator

28 Feb 2017

Increased inclusion period and updated list of associated centers

13 Jun 2017

Closure of investigator center

27 Dec 2017

Closure of investigator centers and change in inclusion criteria for head injury

27 Nov 2018

Increased inclusion period, RGPD compliance, update of investigator centers (opening and closing) and change of principal investigator

11 Sep 2019

Change of principal investigators, closure of investigating centers

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: intracranial hemorrhage

Primary: intracranial hemorrhage

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: intracranial hemorrhage

Primary: intracranial hemorrhage

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Réversion préventive systématique versus réversion en cas d'hémorragie intracranienne chez les patients prenant un traitement antivitamine K et venant de subir un traumatisme cranien léger