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

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00320619
First received: April 28, 2006
Last updated: March 10, 2009
Last verified: March 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Sean Berenholtz, MD, MHS Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Spinal Stenosis
Spondylitis
Bone Diseases
Bone Diseases, Infectious
Infection
Musculoskeletal Diseases
Spinal Diseases
Aminocaproic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014