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Clinical Trials in Emergencies:

When consent might kill you g y

H l Sh k S i L t d C Di t Cli i l T i l U it Haleema Shakur, Senior Lecturer and Co-Director, Clinical Trials Unit

EFGCP Regional Conference on Hot Topics in Clinical Research

October, 2012

(2)

Burden of Injuries j

 About 5.8 million people die each year as a result of injuries

injuries.

 This accounts for 10% of the world’s deaths

32% th d th f

 32% more than deaths from malaria, tuberculosis and HIV/AIDS combined

HIV/AIDS combined.

(3)

Commonly used treatments for TBI y

(4)

The effect of corticosteroids was a highly significant

The effect of corticosteroids was a highly significant 

relative increase of 18% in all cause mortality

(5)
(6)

TXA use in surgery

TXA reduces bleeding in surgery

g y

Transfusion Mortality

RR (95% CI)

Transfusion

RR (95% CI)

Mortality

TXA 0 62 (0 58-0 65) TXA 0 61 (0 38 0 98)

TXA 0.62 (0.58 0.65) TXA 0.61 (0.38-0.98)

TXA better TXA worse

0.4 0.8 1.2 1.6

TXA better TXA worse

0 0.4 0.8 1.2 1.6

TXA better TXA worse TXA better TXA worse

72 trials 

Ker et al. BMC Emergency Medicine 2012, 12:3

95 trials

(7)

CRASH-2 trial profile

20,211 randomised

10,096 allocated TXA 10,115 allocated placebo

1 consent  i hd

3 consent  i hd

10 093 b li d 10 114 b li d

withdrawn withdrawn

10,093 baseline data 10,114 baseline data

47 l

33 l 47 lost 

to follow‐up 33 lost 

to follow‐up

Followed up = 10,060  (99.7%)

Followed up = 10,067  (99.5%)

(8)

Any cause of death

RR (95% CI) TXA

( 10 060)

Placebo ( 10 067) (n= 10,060)

1,463 (14.5%)

(n= 10,067) 1,613 (16.0%)

0.91 (0.85–0.97) 2P=0.0035

0.8 0.9 1.0 1.1

TXA worse TXA better

(9)

Death due to bleeding g

RR (95% CI) TXA

( 10 060)

Placebo ( 10 067) (n= 10,060)

489 (4.9%)

(n= 10,067) 574 (5.7%)

0.85 (0.76–0.96) 2P=0.0077

0.8 0.9 1.0 1.1

TXA worse TXA better

(10)

Bleeding death: early treatment is better

RR (99% CI) p=0.000008

≤1 h 0 68 (0 54 0 86)

≤1 hour 0.68 (0.54–0.86)

1 t ≤ 3 h 0 79 (0 60 1 04)

>1 to ≤ 3 hours 0.79 (0.60–1.04)

1 44 (1 04 1 99)

>3 hours 1.44 (1.04–1.99)

0.85 (0.76–0.96)

1

.7 .8 .9 1.1 1.2 1.3 1.4 1.5

( )

(11)
(12)
(13)
(14)

WAIVER OF CONSENT VS REQUIREMENT FOR REPRESENTATIVE CONSENT

FOR REPRESENTATIVE CONSENT

116 hospitals – 40 countries

4000 patients randomised

4000 patients randomised

78 hospitals REC approved Waiver of Consent

38 hospitals REC approved Requirement for Representative Consent

Waiver of Consent

Required Consent from a

t ti Difference Co se t representative

Time to

d (h ) ( ) ( ) 1 2 hours

randomisation (hours) 3.2 (SE 0.16) 4.4 (SE 0.21) 1.2 hours (p,0.0001) A e age ec itment

Average recruitment

rate per month 2.0 (SE 0.29) 1.5 (SE 0.24) 0.51

Research in emergency situations: with or without relatives consent. The CRASH Trial Management Group: Emerg Med J2004;

21:703.

(15)

What is happening while we wait?

What is happening while we wait?

(16)

Effect of consent rituals on mortality in emergency care research. Lancet March 24, 2011

“we estimate that a 1 hour treatment delaywe estimate that a 1 hour treatment delay reduced the proportion of patients who benefit from the trial treatment from 63% to 49%.”

(17)

Medicines for Human Use Clinical Trials Regulations

Amendment (No 2) 2006 Amendment (No. 2) 2006

If treatment is being, or is about to be, provided for a subject who is an incapacitatedj adult as a matter of

urgency and, having regard to the nature of the clinical trial and of the particular circumstances of the case …..

(18)

Recovery of competence y p

If and when a participant on whose behalf either p p a personal or professional legal representative has given consent to participate in a research has given consent to participate in a research project recovers competence:

She must be informed of her participation. p p

Consent must be obtained to the use of biological

Consent must be obtained to the use of biological

materials or data in the research.

(19)
(20)

Can relatives give fully informed

?

consent in an emergency?

(21)

Lives saved with TXA (every year)

TXA < 1 hour = 128,000 lives TXA 3h 112 000 li TXA < 3hours =112,000 lives

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