PMID- 21610529
OWN - NLM
STAT- MEDLINE
DCOM- 20111019
LR  - 20201209
IS  - 1529-8809 (Electronic)
IS  - 0022-5282 (Linking)
VI  - 71
IP  - 1
DP  - 2011 Jul
TI  - Recombinant activated factor VII safety in trauma patients: results from the 
      CONTROL trial.
PG  - 12-9
LID - 10.1097/TA.0b013e31821a42cf [doi]
AB  - BACKGROUND: Safety data on recombinant activated factor VII (rFVIIa, NovoSeven; 
      Novo Nordisk A/S, Bagsvaerd, Denmark) in actively hemorrhaging trauma patients are 
      limited. We present detailed safety data from a large multicenter, randomized, 
      placebo-controlled phase III study (the CONTROL trial). METHODS: Data from 560 
      patients were analyzed. Subjects were monitored for adverse events (AEs) after 
      rFVIIa or placebo administration. Incidences, timing, and presence of risk 
      factors were reported by site investigators, supported by external study monitors 
      and overseen by an independent Data Monitoring Committee. RESULTS: There were no 
      differences in overall mortality, organ system failure, or AEs, serious AEs, or 
      medical events of special interest. Arterial and venous thromboembolic (TE) 
      events and their risk factors were similar in both groups. The greatest risk 
      factor for TE events was a chest injury requiring mechanical ventilation >3 days 
      (86%). There were four site investigator-reported myocardial infarctions in the 
      rFVIIa group of which only one met diagnostic criteria preestablished by the Data 
      Monitoring Committee. There were no reported myocardial infarctions in the 
      placebo group. Troponins were increased in 30% of all patients. The rate of acute 
      respiratory distress syndrome was lower in the rFVIIa (3.0%) than in the placebo 
      (7.2%) group (p = 0.022). CONCLUSIONS: This represents the largest 
      placebo-controlled dataset of rFVIIa use in trauma patients to date. In this 
      prospective study of critically bleeding trauma patients, rFVIIa use was 
      associated with an imbalance of investigator-reported Acute myocardial 
      infarction/non-ST segment elevation myocardial infarction (AMI/NSTEMI), but was 
      not associated with an increased risk for other AEs, including TE complications.
FAU - Dutton, Richard P
AU  - Dutton RP
AD  - Department of Anesthesiology, University of Maryland Medical System, Baltimore, 
      MD, USA. r.dutton@asahq.org
FAU - Parr, Michael
AU  - Parr M
FAU - Tortella, Bartholomew J
AU  - Tortella BJ
FAU - Champion, Howard R
AU  - Champion HR
FAU - Bernard, Gordon R
AU  - Bernard GR
FAU - Boffard, Kenneth
AU  - Boffard K
FAU - Bouillon, Bertil
AU  - Bouillon B
FAU - Croce, Martin A
AU  - Croce MA
FAU - Dimsits, Jeannett
AU  - Dimsits J
FAU - Holcomb, John B
AU  - Holcomb JB
FAU - Leppaniemi, Ari
AU  - Leppaniemi A
FAU - Vincent, Jean-Louis
AU  - Vincent JL
FAU - Hauser, Carl J
AU  - Hauser CJ
CN  - CONTROL Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Trauma
JT  - The Journal of trauma
JID - 0376373
RN  - 0 (Recombinant Proteins)
RN  - AC71R787OV (recombinant FVIIa)
RN  - EC 3.4.21.21 (Factor VIIa)
SB  - IM
MH  - Europe/epidemiology
MH  - Factor VIIa/*administration & dosage/therapeutic use
MH  - Follow-Up Studies
MH  - Humans
MH  - Incidence
MH  - Multiple Organ Failure/epidemiology/etiology/*prevention & control
MH  - Myocardial Infarction/complications/epidemiology/prevention & control
MH  - Recombinant Proteins/administration & dosage/therapeutic use
MH  - Respiratory Distress Syndrome/complications/epidemiology/prevention & control
MH  - Risk Factors
MH  - Survival Rate
MH  - Thoracic Injuries/*complications/diagnosis
MH  - Thromboembolism/diagnosis/*drug therapy/epidemiology
MH  - Trauma Severity Indices
MH  - Treatment Outcome
MH  - United States/epidemiology
EDAT- 2011/05/26 06:00
MHDA- 2011/10/20 06:00
CRDT- 2011/05/26 06:00
PHST- 2011/05/26 06:00 [entrez]
PHST- 2011/05/26 06:00 [pubmed]
PHST- 2011/10/20 06:00 [medline]
AID - 10.1097/TA.0b013e31821a42cf [doi]
PST - ppublish
SO  - J Trauma. 2011 Jul;71(1):12-9. doi: 10.1097/TA.0b013e31821a42cf.