Case Study: Rescue Therapy

Severe Gastrointestinal (GI) Bleed Secondary to Xarelto with a Hemoglobin-based Oxygen Carrier (Sanguinate) Available as Precautionary Measure

A 78-year old man who is one of Jehovah’s Witnesses presented with fatigue and weakness along with a 4-week history of maroon colored stools. He was recently admitted to another hospital for a pulmonary infection, where he was found to be in atrial fibrillation (AF) and diagnosed with a non-ischemic cardiomyopathy. He was placed on Xarelto, one of the newer anticoagulants, as a preventative measure, due to his AF. His past medical history included hypertension, type-2 diabetes mellitus, mild aortic stenosis, hematuria, and arterio-venous malformations in the gastrointestinal tract.

His hemoglobin upon admission was 4.1 g/dL, which decreased to 3.1 on the 3rd day after admission. Xarelto was discontinued upon admission and he was placed on aspirin 325 mg/day. An upper GI endoscopy, was normal. A colonoscopy revealed a transverse colon polyp but no active bleeding. He also had a video capsule endoscopic exam where a small "pill camera" is swallowed and video pictures of the entire GI tract are recorded. This exam was significant for an arterial-venous malformation (AVM) in the proximal small bowel, which was not actively bleeding at that time. An echocardiogram showed a left-ventricular ejection fraction of 40%, which was much improved over a prior exam at an outside hospital showing a 10% ejection fraction.

His treatment plan included the following regimen given daily:

  • folate 1 mg IV
  • vitamin B12 1,000mcg SQ
  • iron sucrose 200 mg IV
  • erythropoietin 40,000 units IV

Phlebotomy blood loss was minimized using neonatal tubes, which require about 10% of the blood volume compared to the full adult sized tubes.

Given his very low hemoglobin, and his risk factors for coronary artery disease, our team decided to obtain a hemoglobin-based oxygen carrier (Sanguinate), in case he developed congestive heart failure or symptomatic myocardial ischemia. This was procured within 24 hours after the necessary FDA phone calls and paperwork, along with the Johns Hopkins IRB emergency applications. These measures were required given that Sanguinate (and all other hemoglobin based oxygen carriers) are not yet FDA approved, and are only available for "compassionate use". Since the half-life of these compounds is relatively short, the concept is to use them as a temporary measure while the erythropoietic regimen is given to promote red blood cell production. Although the Sanguinate was obtained, its use was not necessary since the patient did not exhibit symptoms, despite severe anemia, and responded well to the erythropoietic therapy.

The hemoglobin level upon discharge on day #7 was 5.1 g/dL. He was not symptomatic from this anemia (his heart rate was 50 bpm). He was sent home on all his prior medications except for Xarelto. Aspirin 325 mg/day, and iron sulfate 325 mg/day were recommended upon discharge. He visited the infusion clinic three times in three weeks, where iron dextran 1 gram IV, and erythropoietin 40,000 units IV, were given during each visit. His last hemoglobin was 11.1 g/dL after these three treatments. He is being followed up by Cardiology, Gastroenterology and Hematology.