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

Scoliosis Clinical Trial

Official title:

Aminocaproic Acid and Bleeding in Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320619
• Other study ID #: 360
• Secondary ID: K23HL070058-03
• Status: Completed
• Phase: N/A
• First received: April 28, 2006
• Last updated: July 28, 2016
• Start date: September 2000
• Est. completion date: February 2006

Study information

• Verified date: March 2009
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kyphosis
• Lordosis
• Scoliosis
• Spinal Stenosis
• Spondylitis

Intervention

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
Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Goodnough LT, Bach RG. Anemia, transfusion, and mortality. N Engl J Med. 2001 Oct 25;345(17):1272-4. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of allogenic blood units transfused		Measured through the 8th postoperative day	No
Secondary	Intraoperative and postoperative blood loss		Measured through the 8th postoperative day	No
Secondary	Intraoperative and postoperative blood products received, including autologous blood, allogenic blood, fresh frozen plasma, platelets, or cryo		Measured through the 8th postoperative day	No
Secondary	Potential complications of transfusion		Measured through the 8th postoperative day	Yes
Secondary	Potential complications of EACA		Measured through the 8th postoperative day	Yes
Secondary	Potential surgical complications		Measured through the 8th postoperative day	Yes
Secondary	Duration of mechanical ventilation		Measured through the 8th postoperative day	No
Secondary	In-hospital mortality		Measured through the 8th postoperative day	No
Secondary	ICU length of stay (LOS)		Measured through the 8th postoperative day	No
Secondary	Hospital LOS		Measured through the 8th postoperative day	No
Secondary	Direct costs of hospital care		Measured through the 8th postoperative day	No