Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00320619

Purpose

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
Scoliosis Kyphosis Lordosis Spondylitis Spinal Stenosis	Drug: Epsilon-Aminocaproic Acid (EACA) Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Aminocaproic Acid and Bleeding in Spinal Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Blood Transfusion and Donation Scoliosis Spinal Stenosis

Drug Information available for: 6-Aminocaproic acid Aminocaproic acid

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Number of allogenic blood units transfused [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Intraoperative and postoperative blood loss [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
Intraoperative and postoperative blood products received, including autologous blood, allogenic blood, fresh frozen plasma, platelets, or cryo [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
Potential complications of transfusion [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: Yes ]
Potential complications of EACA [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: Yes ]
Potential surgical complications [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: Yes ]
Duration of mechanical ventilation [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
In-hospital mortality [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
ICU length of stay (LOS) [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
Hospital LOS [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]
Direct costs of hospital care [ Time Frame: Measured through the 8th postoperative day ] [ Designated as safety issue: No ]

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
Experimental: 1 Participants will receive either EACA.	Drug: Epsilon-Aminocaproic Acid (EACA) Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Placebo Comparator: 2 Participants will receive placebo.	Drug: Placebo Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of spondylosis, pseudoarthrosis, kyphoscoliosis, or acquired or congenital spine deformity
Willing to undergo elective spinal surgery by a participating surgeon; eligible procedures include the following: spine osteotomy, arthrodesis, instrumentation and/or corpectomy, surgery for lumbar spinal stenosis, or surgery for degenerative disc disease

Exclusion Criteria:

Requires urgent or emergent surgery
Has kidney failure that requires dialysis
Has a known bleeding diathesis, defined as a documented history of an inherited bleeding disorder (e.g., hemophilia or von Willebrand's disease) OR prothrombin time ratio greater than 1.5 seconds OR a documented previous arterial or venous thrombosis within 1 year of study entry
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320619

Locations

United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Sean Berenholtz, MD, MHS

Johns Hopkins Medical Institutions

More Information

Publications:

Goodnough LT, Bach RG. Anemia, transfusion, and mortality. N Engl J Med. 2001 Oct 25;345(17):1272-4. No abstract available.

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.

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.

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. 2004 Feb 1;29(3):233-8.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sean Berenholtz, MD, MHS, Johns Hopkins Medical Institutions
ClinicalTrials.gov Identifier:	NCT00320619 History of Changes
Other Study ID Numbers:	360, K23 HL70058-03
Study First Received:	April 28, 2006
Last Updated:	March 10, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Aminocaproic Acids
Blood Transfusion

Additional relevant MeSH terms:

Kyphosis
Lordosis
Swayback
Scoliosis
Spinal Stenosis
Spondylitis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Deficiency Diseases
Malnutrition

Nutrition Disorders
Bone Diseases, Infectious
Infection
6-Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012