Diagnostic and therapeutic methods using heme as a biomarker for cellular and tissue damage

A method of identifying a patient having sterile inflammation, the method comprising:

• (a) determining a level of heme in a biological sample obtained from a patient;
• and
• (b) identifying the patient as having sterile inflammation based on the level of heme in the biological sample from the patent, wherein a level of heme in the biological sample that is at or above a reference level of heme indicates that the patient has sterile inflammation.

A method of assessing sterile inflammation in a patient, the method comprising:

• (a) obtaining a biological sample from the patient no more than five hours after administration of a therapeutic agent or a physical injury to the patient in the absence of bleeding;
• and
• (b) detecting the level of heme in the biological sample.

A method of monitoring a patient undergoing a treatment with a therapeutic agent that causes cellular or tissue toxicity, the method comprising:

• (a) determining a level of heme in a biological sample obtained from the patient at a time point during or after administration of the therapeutic agent;
• and
• (b) comparing the level of heme in the biological sample from the patient with a reference level of heme, thereby monitoring the patient undergoing treatment with the therapeutic agent.

A method of treating or preventing cellular or tissue damage in a patient in need thereof, the method comprising administering an effective amount of a heme scavenger therapy, a CO therapy, or a combination thereof to the patient, wherein the patient has been determined to have a level of heme in the biological sample that is at or above a reference level of heme.

A method of treating or preventing sterile inflammation in a patient in need thereof, the method comprising administering an effective amount of a heme scavenger therapy, a CO therapy, or a combination thereof to the patient, wherein the patient has been determined to have a level of heme in the biological sample that is at or above a reference level of heme.

A kit for assessing cellular or tissue damage in a patient, the kit comprising:

• (a) reagents for determining a level of heme in a biological sample obtained from a patient;
• and
• (b) instructions to identify the patient as having cellular or tissue damage based on the level of heme in the biological sample from the patent, wherein a level of heme in the biological sample that is at or above a reference level of heme indicates that the patient has cellular or tissue damage.

A kit for identifying a patient having sterile inflammation, the kit comprising:

• (a) reagents for determining a level of heme in a biological sample obtained from a patient;
• and
• (b) instructions to identify the patient as having sterile inflammation based on the level of heme in the biological sample from the patent, wherein a level of heme in the biological sample that is at or above a reference level of heme indicates that the patient has sterile inflammation.