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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL070058-03 | U.S. NIH Grant/Contract | View source |
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Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.
Spine surgery is often required to correct a number of diseases, including spondylosis, pseudoarthrosis, scoliosis, or other spinal deformities. Spine surgery is often associated with significant blood loss and individuals may require multiple blood transfusions during and following surgery. Blood transfusions are expensive and carry an increased risk of health complications, including fever, allergic reactions, or infections. Preliminary research has shown that EACA may be beneficial for individuals undergoing spine surgery. In addition, EACA appears to be safer and less expensive than other medications typically used to treat serious bleeding. The purpose of this study is to evaluate the safety and effectiveness of EACA at reducing the number of blood transfusions required during and following spine surgery in adults.
This study will enroll individuals who are undergoing spine surgery at Johns Hopkins Hospital. Prior to surgery, participants' demographic data and medical history will be collected. Participants will then be randomly assigned to receive either EACA or placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU). While in the hospital, participants will have blood drawn frequently for laboratory testing. They will receive blood transfusions as needed and will be closely monitored for blood loss and any medical, surgical, or transfusion complications. Outcome measurements related to the amount of transfused blood required and postoperative complications will be collected on the 8th day following surgery. Study participation will end on the day of hospital discharge or the day of a necessary second surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive either EACA. |
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| 2 | Placebo Comparator | Participants will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epsilon-Aminocaproic Acid (EACA) | Drug | Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of allogenic blood units transfused | Measured through the 8th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative and postoperative blood loss | Measured through the 8th postoperative day | |
| Intraoperative and postoperative blood products received, including autologous blood, allogenic blood, fresh frozen plasma, platelets, or cryo | Measured through the 8th postoperative day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean Berenholtz, MD, MHS | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11680450 | Background | Goodnough LT, Bach RG. Anemia, transfusion, and mortality. N Engl J Med. 2001 Oct 25;345(17):1272-4. doi: 10.1056/NEJM200110253451711. No abstract available. | |
| 10443606 | Background | Troianos CA, Sypula RW, Lucas DM, D'Amico F, Mathie TB, Desai M, Pasqual RT, Pellegrini RV, Newfeld ML. The effect of prophylactic epsilon-aminocaproic acid on bleeding, transfusions, platelet function, and fibrinolysis during coronary artery bypass grafting. Anesthesiology. 1999 Aug;91(2):430-5. doi: 10.1097/00000542-199908000-00017. |
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| Placebo | Drug | Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU). |
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| Potential complications of transfusion | Measured through the 8th postoperative day |
| Potential complications of EACA | Measured through the 8th postoperative day |
| Potential surgical complications | Measured through the 8th postoperative day |
| Duration of mechanical ventilation | Measured through the 8th postoperative day |
| In-hospital mortality | Measured through the 8th postoperative day |
| ICU length of stay (LOS) | Measured through the 8th postoperative day |
| Hospital LOS | Measured through the 8th postoperative day |
| Direct costs of hospital care | Measured through the 8th postoperative day |
| 9390584 | Background | Slaughter TF, Faghih F, Greenberg CS, Leslie JB, Sladen RN. The effects of epsilon-aminocaproic acid on fibrinolysis and thrombin generation during cardiac surgery. Anesth Analg. 1997 Dec;85(6):1221-6. doi: 10.1097/00000539-199712000-00008. |
| 14752343 | Background | Florentino-Pineda I, Thompson GH, Poe-Kochert C, Huang RP, Haber LL, Blakemore LC. The effect of amicar on perioperative blood loss in idiopathic scoliosis: the results of a prospective, randomized double-blind study. Spine (Phila Pa 1976). 2004 Feb 1;29(3):233-8. doi: 10.1097/01.brs.0000109883.18015.b9. |
| 19730217 | Derived | Berenholtz SM, Pham JC, Garrett-Mayer E, Atchison CW, Kostuik JP, Cohen DB, Nundy S, Dorman T, Ness PM, Klag MJ, Pronovost PJ, Kebaish KM. Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery. Spine (Phila Pa 1976). 2009 Sep 1;34(19):2096-103. doi: 10.1097/BRS.0b013e3181b1fab2. |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D007738 | Kyphosis |
| D008141 | Lordosis |
| D013166 | Spondylitis |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015119 | Aminocaproic Acid |
| ID | Term |
|---|---|
| D000614 | Aminocaproates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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