Thursday, January 28, 2010

Clinical Practice Guideline: Red Blood Cell Transfusion in Adult Trauma and Critical Care

Lena M. Napolitano, MD; Stanley Kurek, DO; Fred A. Luchette, MD; Howard L. Corwin, MD; Philip S. Barie, MD; Samuel A. Tisherman, MD; Paul C. Hebert, MD, MHSc; Gary L. Anderson, DO; Michael R. Bard, MD; William Bromberg, MD; William C. Chiu, MD; Mark D. Cipolle, MD, PhD; Keith D. Clancy, MD; Lawrence Diebel, MD; William S. Hoff, MD; K. Michael Hughes, DO; Imtiaz Munshi, MD; Donna Nayduch, RN, MSN, ACNP; Rovinder Sandhu, MD; Jay A. Yelon, MD

Ref: Crit Care Med. 2009;37(12):3134-57. © 2009 Lippincott Williams & Wilkins

Recommendations Regarding Indications for RBC Transfusion in the General Critically Ill Patient

  1. RBC transfusion is indicated for patients with evidence of hemorrhagic shock. (Level 1)
  2. RBC transfusion may be indicated for patients with evidence of acute hemorrhage and hemodynamic instability or inadequate oxygen delivery. (Level 1)
  3. A "restrictive" strategy of RBC transfusion (transfuse when Hb < 7 g/dL) is as effective as a "liberal" transfusion strategy (transfusion when Hb < 10 g/dL) in critically ill patients with hemodynamically stable anemia, except possibly in patients with acute myocardial ischemia. (Level 1)
  4. The use of only Hb level as a "trigger" for transfusion should be avoided. Decision for RBC transfusion should be based on an individual patient's intravascular volume status, evidence of shock, duration and extent of anemia, and cardiopulmonary physiologic parameters. (Level 2)
  5. In the absence of acute hemorrhage RBC, transfusion should be given as single units. (Level 2)
  6. Consider transfusion if Hb < 7 g/dL in critically ill patients requiring mechanical ventilation (MV). There is no benefit of a "liberal" transfusion strategy (transfusion when Hb < 10 g/dL) in critically ill patients requiring MV. (Level 2)
  7. Consider transfusion if Hb < 7 g/dL in resuscitated critically ill trauma patients. There is no benefit of a "liberal" transfusion strategy (transfusion when Hb < 10 g/dL) in resuscitated critically ill trauma patients. (Level 2)
  8. Consider transfusion if Hb < 7 g/dL in critically ill patients with stable cardiac disease. There is no benefit of a "liberal" transfusion strategy (transfusion when Hb < 10 g/dL) in critically ill patients with stable cardiac disease. (Level 2)
  9. RBC transfusion should not be considered as an absolute method to improve tissue oxygen consumption in critically ill patients. (Level 2)
  10. RBC transfusion may be beneficial in patients with acute coronary syndromes (ACS) who are anemic (Hb < 8 g/dL) on hospital admission. (Level 3)

Recommendations Regarding RBC Transfusion in Sepsis

  1. There are insufficient data to support Level 1 recommendations on this topic.
  2. The transfusion needs for each septic patient must be assessed individually since optimal transfusion triggers in sepsis patients are not known and there is no clear evidence that blood transfusion increases tissue oxygenation. (Level 2)

Recommendations Regarding RBC Transfusion in Patients at Risk for or With Acute Lung Injury (ALI) and ARDS

ALI and ARDS are common clinical sequelae of massive transfusion. Prior studies have suggested that RBC transfusion is associated with respiratory complications, including ALI and ARDS that remains even after adjusting for potential confounders.

  1. There are insufficient data to support Level 1 recommendations on this topic.
  2. All efforts should be initiated to avoid RBC transfusion in patients at risk for ALI and ARDS after completion of resuscitation. (Level 2)
  3. All efforts should be made to diagnose and report transfusion-related ALI (TRALI) to the local blood bank because it has emerged as a leading cause of transfusion-associated morbidity and mortality, despite underdiagnosis and underreporting. (Level 2)
  4. RBC transfusion should not be considered as a method to facilitate weaning from MV. (Level 2)

Recommendations Regarding RBC Transfusion in Patients With Neurologic Injury and Diseases

  1. There are insufficient data to support Level 1 Recommendations on this topic.
  2. There is no benefit of a "liberal" transfusion strategy (transfusion when Hb < 10 g/dL) in patients with moderate-to-severe traumatic brain injury. (Level 2)
  3. Decisions regarding blood transfusion in patients with subarachnoid hemorrhage (SAH) must be assessed individually since optimal transfusion triggers are not known and there is no clear evidence that blood transfusion is associated with improved outcome. (Level 3)

Recommendations Regarding RBC Transfusion Risks

  1. There are insufficient data to support Level 1 Recommendations on this topic.
  2. RBC transfusion is associated with increased nosocomial infection (wound infection, pneumonia, sepsis) rates independent of other factors. (Level 2)
  3. RBC transfusion is an independent risk factor for MOF and SIRS. (Level 2)
  4. There is no definitive evidence that prestorage leukocyte depletion of RBC transfusion reduces complication rates, but some studies have shown a reduction in infectious complications. (Level 2)
  5. RBC transfusions are independently associated with longer ICU and hospital length of stay, increased complications, and increased mortality. (Level 2)
  6. There is a relationship between transfusion and ALI and ARDS. (Level 2)

Recommendations Regarding Alternatives to RBC Transfusion

  1. There are insufficient data to support Level 1 recommendations on this topic.
  2. Recombinant human erythropoietin (rHuEpo) administration improves reticulocytosis and hematocrit and may decrease overall transfusion requirements. (Level 2)
  3. Hemoglobin-based oxygen carriers (HBOCs) are undergoing investigation for use in critically ill and injured patients but are not yet approved for use in the United States. (Level 2)

Recommendations Regarding Strategies to Reduce RBC Transfusion

  1. There are insufficient data to support Level 1 recommendations on this topic.
  2. The use of low-volume adult or pediatric blood sampling tubes is associated with a reduction in phlebotomy volumes and a reduction in blood transfusion. (Level 2)
  3. The use of blood conservation devices for reinfusion of waste blood with diagnostic sampling is associated with a reduction in phlebotomy volume. (Level 2)
  4. Intraoperative and postoperative blood salvage and alternative methods for decreasing transfusion may lead to a significant reduction in allogeneic blood usage. (Level 2)
  5. Reduction in diagnostic laboratory testing is associated with a reduction in phlebotomy volumes and a reduction in blood transfusion. (Level 2)

Monday, January 4, 2010

New FDA Alert on Clopidogrel-PPI Interaction

The FDA has today issued a new public-health warning on the possible interaction between clopidogrel and the proton-pump inhibitor (PPI) omeprazole. The alert states: "New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole."

The FDA alert says the new information on which its warning is based comes from new studies that compared the amount of clopidogrel's active metabolite in the blood and its effect on platelets in people who took clopidogrel plus omeprazole vs those who took clopidogrel alone. A reduction in active metabolite levels of about 45% was found in people who received clopidogrel with omeprazole compared with those taking clopidogrel alone. The effect of clopidogrel on platelets was reduced by as much as 47% in people receiving clopidogrel and omeprazole together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the statement adds.

Based on the current scientific information, the clopidogrel label has been updated with new warnings on omeprazole and other drugs that inhibit the CYP2C19 enzyme that could interact with clopidogrel in the same way. In addition, the manufacturer of clopidogrel is conducting follow-up studies to explore this and other drug interactions.

It adds that patients who use clopidogrel and need a medication to reduce stomach acid can use antacids or H2 antagonists such as ranitidine, famotidine, or nizatidine, because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel. However,cimetidine should not be used, it says.

It also says that other drugs that are potent inhibitors of the CYP2C19 enzyme would be expected to have a similar effect and should be avoided in combination with clopidogrel. These include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. "Since the level of inhibition among other PPIs varies, it is unknown to what amount other PPIs may interfere with clopidogrel. However, esomeprazole, a PPI that is a component of omeprazole, inhibits CYP2C19 and should also be avoided in combination with clopidogrel," it adds.

Ref: Food and Drug Adminstration. Public-health advisory: Updated safety information about a drug interaction between clopidogrel bisulfate (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC). November 17, 2009. [http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm190825.htm]

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