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

Primary Purpose

Scoliosis, Kyphosis, Lordosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epsilon-Aminocaproic Acid (EACA)
Placebo
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Aminocaproic Acids, Blood Transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will receive either EACA.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Number of allogenic blood units transfused

Secondary Outcome Measures

Intraoperative and postoperative blood loss
Intraoperative and postoperative blood products received, including autologous blood, allogenic blood, fresh frozen plasma, platelets, or cryo
Potential complications of transfusion
Potential complications of EACA
Potential surgical complications
Duration of mechanical ventilation
In-hospital mortality
ICU length of stay (LOS)
Hospital LOS
Direct costs of hospital care

Full Information

First Posted
April 28, 2006
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00320619
Brief Title
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Official Title
Aminocaproic Acid and Bleeding in Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Kyphosis, Lordosis, Spondylitis, Spinal Stenosis
Keywords
Aminocaproic Acids, Blood Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive either EACA.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Epsilon-Aminocaproic Acid (EACA)
Intervention Description
Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Primary Outcome Measure Information:
Title
Number of allogenic blood units transfused
Time Frame
Measured through the 8th postoperative day
Secondary Outcome Measure Information:
Title
Intraoperative and postoperative blood loss
Time Frame
Measured through the 8th postoperative day
Title
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
Title
Potential complications of transfusion
Time Frame
Measured through the 8th postoperative day
Title
Potential complications of EACA
Time Frame
Measured through the 8th postoperative day
Title
Potential surgical complications
Time Frame
Measured through the 8th postoperative day
Title
Duration of mechanical ventilation
Time Frame
Measured through the 8th postoperative day
Title
In-hospital mortality
Time Frame
Measured through the 8th postoperative day
Title
ICU length of stay (LOS)
Time Frame
Measured through the 8th postoperative day
Title
Hospital LOS
Time Frame
Measured through the 8th postoperative day
Title
Direct costs of hospital care
Time Frame
Measured through the 8th postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Berenholtz, MD, MHS
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11680450
Citation
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.
Results Reference
background
PubMed Identifier
10443606
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. doi: 10.1097/00000542-199908000-00017.
Results Reference
background
PubMed Identifier
9390584
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. doi: 10.1097/00000539-199712000-00008.
Results Reference
background
PubMed Identifier
14752343
Citation
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.
Results Reference
background
PubMed Identifier
19730217
Citation
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.
Results Reference
derived

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

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