Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Aminocaproic Acid and Bleeding in Spinal Surgery
2 other identifiers
interventional
182
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedJuly 29, 2016
March 1, 2009
5.4 years
April 28, 2006
July 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of allogenic blood units transfused
Measured through the 8th postoperative day
Secondary Outcomes (10)
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
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
- +5 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALParticipants will receive either EACA.
2
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (5)
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.
PMID: 11680450BACKGROUNDTroianos 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.
PMID: 10443606BACKGROUNDSlaughter 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.
PMID: 9390584BACKGROUNDFlorentino-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.
PMID: 14752343BACKGROUNDBerenholtz 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.
PMID: 19730217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean Berenholtz, MD, MHS
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 28, 2006
First Posted
May 3, 2006
Study Start
September 1, 2000
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
July 29, 2016
Record last verified: 2009-03