TOW the trials

Magpie:

multicentre RCT 10000 women

mag sulph vs placebo

primary outcomes: eclampsia and death of baby

result: 58% lower risk of eclampsia, lower maternal mortality, no diff in baby mortality

TRACman

tracheostomy : early vs late

multicentre prospective RCT

early 1-4, late not before day 10

primary outcome : 30day mortality

CESAR trial:

conventional ventilatory support vs ECMO in severe adult respi failure

mortality and disability lower in ECMO group , likely to be cost effective

VASST trial

vasopressin and septic shock:

low dose 0.01-0.03u/min or norad

NO in ARDS:

no sig diff in groups in mortality, duration, ventilator free days

no group: higher pao2/fio2 on day 1, but increased risk of renal dysfunciton

ENIGMA I

2050 patients,
non cardiac surgery >2 hrs with or without nitrous

followed up max 5.7 years (median 3.5)
primary end point= survival

a/w long term AMI risk but not death or stroke

need further RCT

MASTER trial

Rigg, et al. Lancet 2002; 359:1276-1282

multicentre RCT in Australia 1995-2001

P:high risk patients undergoing major abdominal surgery, 915 patients

I: intraop epid and post op epid for 72 hr

C:GA

O: mortality at 30 days or major post op morbidity

of all complications: only respi failure less frequent, pain scores over first 3 days were significantly lower.- may be some benefit
low risk of serious adverse reactions

NO SIGNIFICANT DIFFERENCE OVERALL

novoseven Control trial

Results of the CONTROL Trial: Efficacy and Safety of Recombinant Activated Factor VII in the Management of Refractory Traumatic Hemorrhage

C Hauser et al. J Trauma. Sept 2010: 69(3); 489-500

481 blunt and 92 penetrating) who bled 4 to 8 red blood cell (RBC) units Patients were assigned to rFVIIa (200 μg/kg initially; 100 μg/kg at 1 hour and 3 hours

Results: Enrollment was terminated at 573 of 1502 planned patients because of unexpected low mortality prompted by futility analysis (10.8% vs. 27.5% planned/predicted) and difficulties consenting and enrolling sicker patients. Mortality was 11.0% (rFVIIa) versus 10.7% (placebo) (p = 0.93, blunt) and 18.2% (rFVIIa) versus 13.2% (placebo) (p = 0.40, penetrating). Blunt trauma rFVIIa patients received (mean ± SD) 7.8 ± 10.6 RBC units and 19.0 ± 27.1 total allogeneic units through 48 hours, and placebo patients received 9.1 ± 11.3 RBC units (p = 0.04) and 23.5 ± 28.0 total allogeneic units (p = 0.04). Thrombotic adverse events were similar across study cohorts.

Conclusions: rFVIIa reduced blood product use but did not affect mortality compared with placebo. Modern evidence-based trauma lowers mortality, paradoxically making outcomes studies increasingly difficult.