Learning Objectives

At the conclusion of this educational activity, participants should be able to:

• Explain the management of ongoing intraoperative and postoperative bleeding.
• Describe the signs and symptoms of hypovolemic shock.
• Identify key features of a culture of safety that empowers all team members to express safety concerns.

The Case

A 67-year-old man, in excellent health except for seasonal allergies and mild lower urinary tract symptoms (LUTS), developed severe low back pain. His only medications were nasal fluticasone and oral tamsulosin. After thorough evaluation and imaging, he was scheduled for anterior lumbar interbody fusion (ALIF) with bone autograft from the iliac crest.

The operation was performed by two surgeons; the senior spine surgeon performed the ALIF while the junior surgeon managed the incision and the bone graft donor site. The circumstances are unclear, but there was difficulty achieving intraoperative hemostasis, and the patient left the operating room (OR) with the bone graft donor site open and oozing blood. He was still bleeding in the postanesthesia care unit (PACU), where the nurse called the attending physician three times to report hypotension and oozing blood. Each time, the surgeon ordered hetastarch for volume expansion. The patient was transferred to a general surgical recovery bed, with vital signs ordered every 4 hours. Over the next 14 hours, the patient’s blood pressure remained at or below 90/60, and he was described as diaphoretic, clammy, and pale, with a weak and thready pulse. He complained of back and pelvic pain, not feeling right, and expressed feelings of impending doom.

The next morning, the nurse found the patient to be “asleep” and “unresponsive.” On surgical rounds, he was noted to be in hypovolemic shock and the team immediately ordered laboratory tests and a blood transfusion. Imaging of the surgical site was ordered, but before it could be completed, cardiac biomarkers returned, and electrocardiography confirmed a non-ST segment elevation myocardial infarction (NSTEMI). The patient was transferred to an intensive care unit and resuscitative efforts were initiated, but the patient expired from multiorgan failure resulting from hypovolemic shock.

The Commentary

By Scott Zakaluzny, MD, FACS

Background

This is a case of an elective procedure complicated by bleeding; the management of the bleeding was apparently to pack the wound and leave it open. This approach was not adequate and led to continued postoperative bleeding and eventual death from untreated hemorrhagic shock. This case presents several patient safety issues: 1) failure of the operative team to appropriately manage intraoperative bleeding, 2) failure of the system to acknowledge staff raising concerns, 3) failure to recognize and treat hemorrhagic shock, and 4) inappropriate management of hemorrhagic shock.

Management of Intraoperative Bleeding

The management of intraoperative bleeding includes two main considerations. The first is evaluating and treating any contributing coagulopathy, along with supporting the patient if the bleeding is sufficient to require transfusion. The second is how the surgical team works together to control bleeding.

Management of the persistently bleeding patient starts with assessment of their coagulation status. If active resuscitation and transfusion are required, assessment of coagulation occurs in conjunction with ongoing treatment of hemorrhage. Knowing before the operation whether the patient has a history of any bleeding problems and whether they are taking any anticoagulants, including antiplatelet agents, is an important starting point. Standard coagulation tests (i.e., International Normalized Ratio, Activated Partial Thromboplastin Time) are helpful in patients with non-life-threatening bleeding. In acute bleeding, thromboelastography can provide more timely results but may not be available at many hospitals. It is also important to assure the patient is not hypothermic, as this state can contribute to coagulopathy.¹ Laboratory test results can guide appropriate administration of therapies to correct coagulopathy such as platelets, fresh frozen plasma (FFP), prothrombin complex concentrate (PCC), desmopressin, or tranexamic acid.

The surgical management of ongoing and unexpected bleeding in the OR is generally discussed in terms of specific procedures. Ironically for this case, the greatest risk of bleeding from ALIF is usually from injury to a major vein during exposure of the anterior lumbar spine, not from harvesting a bone graft from the iliac crest. Major vascular injury (e.g., left common iliac vein, inferior vena cava, or iliolumbar vein), occurs in 0-18% of ALIF cases,² whereas bleeding is relatively uncommon from an iliac crest bone graft donor site.³ It is unclear whether inexperience of the junior surgeon or lack of communication between the junior and senior surgeons contributed to mismanagement of bleeding from the bone graft site. In any case, leaving the bone graft site open and allowing ongoing bleeding from the site at the end of the procedure are both unusual.⁴

Although specific to gynecologic surgery, Gostout and colleagues provide a useful framework for what to do when encountering unexpected intraoperative bleeding.⁵ The first basic technique is to apply direct pressure. If there is bleeding from a major vessel, the operator aims to achieve proximal and distal control of in-flow and out-flow, potentially with a tourniquet or clamp. In this case with diffuse surface bleeding, maintaining direct pressure would likely entail packing the wound. Packing in conjunction with the use of a local hemostatic agent resolves most cases of mild to moderate bleeding. Specifically for this case involving bone, bone wax is a helpful adjunct. Direct pressure is useful because it gives the surgeon time to get assistance, to clear the operative field, to achieve adequate exposure, and to identify pertinent anatomy both to control bleeding and to prevent injury to other structures. Seeking the assistance of a colleague not only provides an extra set of hands but a fresh set of eyes that can lead to solutions the operator may have overlooked. If the bleeding cannot be controlled surgically, the patient may need evaluation for an endovascular solution with interventional radiology or vascular surgery.

When initial efforts to control bleeding are unsuccessful, it is appropriate to institute damage control surgery, even in an elective case such as spinal fusion. Damage control surgery is the shift from completing a procedure to gaining control of bleeding and contamination, temporarily covering or closing the wound, and stabilizing the patient for completion of the case at another time. The surgical team must determine whether the patient requires correction of coagulopathy, including contributing factors such as acidosis and hypothermia, while continuously re-evaluating the need for further surgical exploration. The operative field may be packed for hemostasis without completing the procedure, temporarily covering or closing, and requesting endovascular evaluation to control difficult-to-access bleeding. Packing the wound in this case may have been an appropriate plan to start, but the lack of further intervention when the bleeding continued was inappropriate.

Approaches to Improving Patient Safety

Once the initial management failed and the patient continued to bleed, the case describes a system and team that “failed to rescue.”^6,7 The postoperative nurse initially appropriately raised a flag of concern, but the same outcome came from three alerts. The concept of high reliability organizations and the culture of safety in industries such as the airline industry has been imported into medicine, with numerous articles and books on the topic. For example, Mlaver and Sweeney discussed establishing this culture in surgical care and stated, “team members should be empowered to express safety concerns.”⁸ In this case, the postoperative nurse and overnight staff did not raise specific concerns about this patient’s status and care. The reasons for this inaction are unclear, but one can assume they were not in an environment where raising concerns was encouraged and embraced.

One mechanism that could have been used is from TeamSTEPPS^TM, “a systematic approach developed by the Department of Defense and the Agency for Healthcare Research and Quality (AHRQ) to integrate teamwork into practice.” The process uses the acronym ‘CUS’ to stand for Concern, Uncomfortable, and Safety. A team member expresses a concern, as was done in this case with a patient having blood-soaked dressings and signs of poor perfusion in the recovery room. However, when the concern is dismissed or ignored, the team member re-addresses it by stating they are uncomfortable and expressing their concern for safety. In a safety-conscious, highly reliable organization, this final step triggers a hard stop. According to the “two-challenge rule,” when an initial assertive statement is ignored, and the provider assertively restates the concern (CUS), but the response does not clarify and alleviate the provider’s concern, then the anticipated danger should be rephrased, other team members should be engaged, and the chain of command should be used. The goal is to empower anyone to be able to halt the process (“stop the line”) for a safety concern. Although the nurse raised the concern by calling three times, we do not know the language used. Presumably the patient’s condition improved temporarily with volume expansion but given the need for three boluses and the patient’s ongoing hypotension after leaving the PACU, the problem was not addressed satisfactorily. In a highly reliable organization, the nursing staff’s concern would have been elevated when it became clear that the surgical team was not being sufficiently responsive, and the patient’s condition was still deteriorating.

The vignette provides little discussion about what occurred overnight as the patient’s status continued to decline. The patient is documented to have been hypotensive, which should have triggered more aggressive interventions. With the additional signs of ‘diaphoretic, clammy, and pale, with a weak and thready pulse,’ the diagnosis of shock from hypovolemia and hemorrhage is obvious. The patient apparently expressed "feelings of impending doom," but it is not clear whether cultural or communication barriers, or implicit bias related to the patient's age or post-anesthesia cognitive status, may have led the team to ignore this alarming symptom. The constellation of symptoms is clear in retrospect, and it is surprising that nothing was done to address it.

Potentially, the nursing staff was unaware there was a life-threatening problem, but such a knowledge deficit seems highly unlikely given abnormal vital signs with ongoing hypotension. Presumably, the nurse received a hand-off about the patient’s PACU course and was told that hypotension was not a new issue. That nurse may have responded by anchoring on the previous complacency, leading to false reassurance. Perhaps more likely, the nurse may have been working in an environment where raising concerns was discouraged. Knowing the patient’s course in the PACU, the nurse was unlikely to awaken the same surgeon at night who was overtly dismissive of the concerns previously raised. In the absence of action by individual nurses or physicians, a systematized electronic health record-based process for identifying deteriorating patients, such as the Modified Early Warning System, could have triggered independent evaluation by a rapid response team, and potentially more timely treatment with blood products.

Lastly, the medical management of the patient’s bleeding is of concern. The use of hetastarch as a volume expander is controversial, and not typical practice, especially in the setting of hemorrhagic shock.^9,10 Any requirement for volume expansion should prompt investigation into why there is a need for volume expansion and to identify the cause of hypovolemia.¹¹ In the morning, when the patient was found to be in hemorrhagic shock, immediate treatment was imperative. Ordering laboratory tests and imaging, as done in this patient, only delays treatment of the shock and associated coagulopathy. Emergency release blood and immediate transfusion should have been initiated with laboratory testing and imaging as distant secondary concerns. The detection of an NSTEMI in this case almost certainly represents a red herring that was a consequence of hemorrhagic shock as the patient’s heart tried to compensate, and not a cause of the patient’s deterioration.

When there is ongoing bleeding requiring massive transfusion, blood should be transfused in a ratio of components that simulates the composition of whole blood to help correct the coagulopathy that likely exists from hemorrhage and ongoing shock. Ideally, all hospitals should establish a massive transfusion protocol (MTP) that can be instituted in appropriate situations. If an MTP is activated, the blood bank can send a cooler with blood, FFP, and platelets in the appropriate ratios. Protocols can also prompt reminders to give calcium and for the provider to assess the appropriateness of other adjuncts for coagulopathy such as tranexamic acid. Component therapy should be administered by transfusing components in a 1:1:1 ratio of FFP to packed red blood cells to platelets as best practice established in the PROPPR trial.¹² In addition to assuring adequate intravenous access for large volume transfusion, blood products should ideally be given through a warmer to help correct and prevent hypothermia, which may contribute to coagulopathy.

Conclusion

This patient was unfortunately cared for by a surgical team that inappropriately managed intraoperative bleeding. This problem was compounded when they continued to ignore signs of ongoing postoperative bleeding. Although nurses identified signs of hemorrhagic shock, the system was not set up to support rapid response and rescue actions. The nurses at the bedside were apparently unable to elevate their concerns, as TeamSTEPPS instructs, and have them properly addressed in a culture of safety. Lastly, when the patient was finally identified to be in hemorrhagic shock and there was a last opportunity to save the patient, the appropriate urgency was not applied as evidenced by ordering laboratory tests and imaging, instead of focusing all attention on transfusion, active resuscitation, and surgical exploration.

Take Home Points

• Active bleeding, especially hemorrhage with signs such as hypotension or shock, should be managed in a deliberate fashion:
  • Stop the bleeding, initially with direct pressure, then with damage control surgery and/or endovascular interventions, if needed.
  • Correct any suspected coagulopathy, including contributing factors such as acidosis and hypothermia.
  • When bleeding is brisk, laboratory results are typically not available fast enough to help guide clinical decision making.
  • Resuscitation with blood products in appropriate ratios has been proven to be more effective than waiting for test results.
• A culture of safety should enable anybody on the care team to raise concerns and have them appropriately addressed. In a high-reliability organization, all staff are empowered to halt the process (“stop the line”) for a persistent safety concern.

Scott Zakaluzny, MD, FACS
Department of Surgery
Division of Trauma, Acute Care Surgery, and Surgical Critical Care
UC Davis Health
szakaluzny@ucdavis.edu

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