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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00320619 |
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.
Condition | Intervention |
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Scoliosis Kyphosis Lordosis Spondylitis Spinal Stenosis |
Drug: Epsilon-Aminocaproic Acid (EACA) Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Aminocaproic Acid and Bleeding in Spinal Surgery |
Enrollment: | 182 |
Study Start Date: | September 2000 |
Study Completion Date: | February 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive either EACA.
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Drug: Epsilon-Aminocaproic Acid (EACA)
Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
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2: Placebo Comparator
Participants will receive placebo.
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Drug: Placebo
Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Sean Berenholtz, MD, MHS | Johns Hopkins Medical Institutions |
Responsible Party: | Johns Hopkins Medical Institutions ( Sean Berenholtz, MD, MHS ) |
Study ID Numbers: | 360, K23 HL70058-03 |
Study First Received: | April 28, 2006 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00320619 History of Changes |
Health Authority: | United States: Federal Government |
Aminocaproic Acids Blood Transfusion |
Spinal Diseases Scoliosis Kyphosis Constriction, Pathologic Hemorrhage Bone Diseases 6-Aminocaproic Acid Hemostatics |
Spinal Stenosis Fibrin Modulating Agents Antiplasmin Antifibrinolytic Agents Musculoskeletal Diseases Lordosis Spondylitis |
Spinal Diseases Scoliosis Coagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Kyphosis Infection Bone Diseases 6-Aminocaproic Acid Hemostatics |
Pharmacologic Actions Spinal Stenosis Bone Diseases, Infectious Fibrin Modulating Agents Spinal Curvatures Antifibrinolytic Agents Musculoskeletal Diseases Therapeutic Uses Lordosis Spondylitis |