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Three Part Question

In [trauma patients with major blood loss and intractable bleeding requiring massive transfusion] does [recombinant factor VIIa] reduce [morbidity and mortalilty]

Clinical Scenario

A 29 year old male is brought into resuscitation area having jumped out of a fourth floor window. He has abdominal and pelvic injuries but no chest, head or limb injuries. He is bleeding intractably and the orthopaedic team and surgical team cannot agree on a plan of management. You suggest that operative managment is required, they would like to perform a CT scan prior to theatre to determine who will lead the surgery. Exasperated you wonder whether factor VIIa would help to stabilise the patient and reduce his requirement for transfusion.

Search Strategy

Medline 1966-07/02 using the OVID interface
[exp Factor VII OR exp Factor VIIa OR (factor adj5 VII).af OR (factor adj5 VIIa).af OR rFVIIa.af] AND [exp hemorrhage OR hemorrhage.af OR exp haemorrhage.af OR bleeding.af. OR (blood adj5 loss).af] AND [exp "Wounds and Injuries" OR trauma.af OR injur$.af OR wound$.af] LIMIT to human AND English.

Search Outcome

59 papers were found of which 2 were relevant and are shown in the table.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Kenet G et al, 1999, Israel	One 19 year old male soldier with life threatening bleeding from IVC	Case report	Mortality	Slowing of blood loss and surgical control of bleeding was achieved with two doses of recombinant factor VIIa	Only one case example
Martinowitz U et al, 2001, Israel	Seven massively bleeding, multitransfused, coagulopathic trauma patients were treated with recombinant factor VIIa after failure of conventional methods to achieve haemostasis.	Case series	Reduction in transusion requirements	From 25-49 units, to 1-2 units	Small study No controls
			Shortening of PTR and APTT	Reduction from 20-31.8 seconds, to 8-12 seconds and 46-110 seconds to 28-46 seconds respectively
			Increase in factor VII levels	From 0.7-0.92 IU/ml, to 18-44 IU/ml
			Mortality	3 of 7 patients died of reasons other than bleeding or thromboembolism

Comment(s)

More studies are needed.

Editor Comment

Updated papers at Recombinant activated Factor VII (rFVIIa) yet to demonstrate a clear mortality benefit in trauma patients needing massive transfusion. http://www.bestbets.org/bets/bet.php?id=1715

Clinical Bottom Line

Factor VIIa may have a role as a temporising adjunct to surgical haemostasis. Further research is needed.

References

1. Kenet G, Walden, Eldad A, et al. Treatment of traumatic bleeding with recombinant factor VIIa Lancet 1999;354:1879.
2. Martinowitz U, Kenet G, Segal E, et al. Recombinant activated factor VII for adjunctive haemorrhage control in trauma J Trauma Injury Infect Crit Care 2001;51(3):431-8, 438-9.