MultiCenter Trials Committee

Early use of Factor VIIa in critically injured patients A prospective, randomized trial

Hypothesis: Early administration of a large, single dose of Factor VIIa in hemodynamically unstable trauma patients will significantly reduce total blood loss and allow faster correction of hemorrhagic shock.

Rationale: Multiple case reports in trauma and non-trauma hemorrhagic disasters have demonstrated reduction in bleeding after administration of Factor VIIa, with minimal side effects. A trial started in South Africa is ongoing, but FDA approval has been stalled over dosing regimens. The Israeli’s reported on 24 trauma patients and are now issuing Factor VIIa to first responders.

Study Design: Prospective, randomized prehospital and/or ED Trial

Prehospital Inclusion Criteria: Hypotensive (BP < 90 systolic) trauma patients (blunt and penetrating) failing to normalize with 2 liters NS or only transiently improving will be randomized to placebo vs. FactorVIIa.

ED Inclusion Criteria: patients requiring blood transfusions within the first hour of resuscitation will be randomized.

Exclusion Criteria: children/pregnancy/prisoners/others?; history of DVT/PE or PVOD?

Consent:??

Data sets:

• Standard trauma registry data including AIS/demographics/ISS
• Standard physiologic data in field/ED/OR/ICU; serial base deficits
• External bleed sources requiring control (i.e.: open fractures, etc)
• Time to correction of base deficit/operative control of hemorrhage
• Internal bleeding quantification: chest tube drainage; estimation of blood loss via CT scan of head/abdomen/chest/pelvis
• Need for operative/angiographic control of bleeding sources
• Total amount of blood/fluids required during resuscitation and operation
• Thrombotic complications: DVT/PE/arterial; at least 1 duplex scan
• Outcome data: death/multi-organ dysfunction
• Cost analysis data?