EFFECT OF PROGESTRONE IN PATIENTS WITH SEVERE TRAUMATIC BRAIN INJURY

Figures & data

Table 1. Marshall scoring of TBI

	MLS	Cisterns	High or mixed-density lesion	Notes
I	None	Present	None	No visible pathology on CT scan
II	0–5 mm	Present	None
III	0–5 mm	Compressed or absent	None	Swelling
IV	>5 mm		None
V	Any	Any	Any	Any lesion surgically evacuated
VI			>25 cm^3	Not surgically evacuated

*MLS-midline shift.

Table 2. Comparison between the two studied groups according to demographic data

	Cases (group 2) (n = 25)		Control (group 1)(n = 25)		Test of Sig.	p
	No.	%	No.	%
Sex
Male	17	68.0	17	68.0	χ^2=0.0	1.000
Female	8	32.0	8	32.0
Age (years)
Min. – Max.	18.0–55.0		18.0–60.0		t = 0.538	0.593
Mean ± SD.	33.36 ± 11.56		35.28 ± 13.61
Median (IQR)	31.0 (26.0–40.0)		32.0 (25.0–45.0)

χ²: Chi square testt: Student t-test.

p: p value for comparing between the studied groups.

Table 3. Comparison between the two studied groups according to APACHEII score and SOFA score

		Cases (group 2)(n = 25)	Control (group 1)(n = 25)	t	p
APACHEII score	On admission
	Min. – Max.	14.0–25.0	13.0–23.0	0.924	0.360
	Mean ± SD.	18.68 ± 2.94	17.88 ± 3.18
	Median (IQR)	18.0 (17.0–21.0)	17.0 (15.0–21.0)
SOFA score	Day 1
	Min. – Max.	8.0–16.0	7.0–19.0	0.221	0.826
	Mean ± SD.	11.32 ± 2.27	11.48 ± 2.83
	Median (IQR)	11.0 (9.0–13.0)	11.0 (9.0–13.0)
	Day 3
	Min. – Max.	7.0–14.0	8.0–18.0	2.808*	0.007*
	Mean ± SD.	9.56 ± 1.78	11.24 ± 2.40
	Median (IQR)	10.0 (8.0–11.0)	11.0 (9.0–13.0)
	Day 5
	Min. – Max.	5.0–12.0	8.0–17.0	5.296*	<0.001*
	Mean ± SD.	7.76 ± 1.67	10.60 ± 2.10
	Median (IQR)	8.0 (7.0–9.0)	10.0 (9.0–12.0)
	Day 7
	Min. – Max.	3.0–11.0	7.0–16.0	7.221*	<0.001*
	Mean ± SD.	6.36 ± 1.85	10.28 ± 1.99
	Median (IQR)	6.0 (5.0–7.0)	10.0 (9.0–11.0)
	p1	<0.001*	<0.001*

t: Student t-testp: p value for comparing between the two studied groups.

p₁: p value forPaired t-testfor comparing between day 1and day7in the same group.

*: Statistically significant at p ≤ 0.05.

Figure 1. Comparison between the two studied groups according to GCS

Figure 2. Comparison between the two studied groups according to CT brain Marshall scoring

Table 4. Comparison between the two studied groups according to GOS, mechanical ventilation days, ICU duration and mortality rate

GOS	Cases (group 2)(n = 25)		Control (group1)(n = 25)				t	p
Day 7
Min. – Max.	1.0–5.0		1.0–5.0				2.085*	0.042*
Mean ± SD.	2.84 ± 1.43		3.56 ± 0.96
Median (IQR)	3.0 (1.0–4.0)		4.0 (3.0–4.0)
Day 28
Min. – Max.	1.0–5.0		1.0–5.0				2.621*	0.012*
Mean ± SD.	3.0 ± 1.63		1.92 ± 1.26
Median (IQR)	3.0 (1.0–4.0)		1.0 (1.0–3.0)
p1	0.637		<0.001*
Mechanical ventilation days	Cases (group 2)(n = 25)		Control (group 1)(n = 25)				t	p
Min. – Max.	2.0–8.0		5.0–15.0				8.426*	<0.001*
Mean ± SD.	4.24 ± 1.33		8.52 ± 2.16
Median (IQR)	4.0 (3.0–5.0)		8.0 (7.0–9.0)
ICU duration (days)	Cases (group 2)(n = 25)		Control (group1)(n = 25)				t	p
Min. – Max.	4.0–11.0		6.0–16.0				5.059*	<0.001*
Mean ± SD.	7.20 ± 1.71		10.48 ± 2.76
Median (IQR)	7.0 (6.0–8.0)		10.0 (8.0–13.0)
Mortality rate	Cases (group 2)(n = 25)			Control (group1)(n = 25)		χ^2			p
	No.	%		No.	%
Day 7
Died	6	24.0		12	48.0	3.125			0.077
Survived	19	76.0		13	52.0
Day 28
Died	8	32.0		16	64.0	5.128*			0.024*
Survived	17	68.0		9	36.0

χ2: Chi square test t: Student t-test.

p₁: p value for Paired t-test for comparing between day 7 and day 28 in the same group.

p: p value for comparing between the two studied groups*: Statistically significant at p ≤ 0.05.

Table

Eyes:
Opens eyes spontaneously.	4
Opens eyes in response to verbal command.	3
Opens eyes in response to painful stimuli.	2
Does not open eyes.	1
Verbal:
Oriented, converses normally.	5
Confused, disoriented.	4
Inappropriate words.	3
Incomprehensible sounds.	2
Makes no sounds.	1
Motor:
Obeys commands.	6
Localizes painful stimuli.	5
Withdrawal to painful stimuli.	4
Flexion to painful stimuli.	3
Extension to painful stimuli.	2
Makes no movements.	1

Table

SOFA Score	0	1	2	3	4
Respiration PaO2/FIO2(mmHg) SaO2/FIO2	>400	<400 221–301	<300 142–220	<200 67–141	<100 <67
Coagulation Platelets (10^3/mm^3)	>150	<150	<100	<50	<20
Liver Bilirubin (mg/dL)	<1.2	1.2–1.96	2.0–5.9	6.0–11.9	>12.0
Cardiovascular Hypotension	No	MAP<70	Dopamine ≤5 or dobutamine (any)	Dopamine>5 or norepinephrine ≤0.1	Dopamine>15 or norepinephrine >0.1
CNS Glasgow Coma Score (GCS)	15	13–14	10–12	6–9	<6
Renal Creatinine (mg/dL) or urine output (mL/d)	<1.2	1.2–1.9	2.0–3.4	3.5–4.9 or <500	>5.0 or <200

Minimum = 0, maximum = 24.

Table

1. Death	Severe injury or death without recovery of consciousness
2. Persistent vegetative state	Severe damage with prolonged state of unresponsiveness and a lack of higher mental functions
3. Severe disability	Severe injury with permanent need for help with daily living
4. Moderate disability	No need for assistance in everyday life, employment is possible but may require special equipment.
5. Low disability	Light damage with minor neurological and psychological deficits.