Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00320619
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : July 29, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date  ICMJE April 28, 2006
First Posted Date  ICMJE May 3, 2006
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE September 2000
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2009)
Number of allogenic blood units transfused [ Time Frame: Measured through the 8th postoperative day ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
Number of allogenic blood units transfused (measured through the 8th postoperative day)
Change History Complete list of historical versions of study NCT00320619 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2009)
  • Intraoperative and postoperative blood loss [ Time Frame: Measured through the 8th postoperative day ]
  • 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 ]
  • Potential complications of transfusion [ Time Frame: Measured through the 8th postoperative day ]
  • Potential complications of EACA [ Time Frame: Measured through the 8th postoperative day ]
  • Potential surgical complications [ Time Frame: Measured through the 8th postoperative day ]
  • Duration of mechanical ventilation [ Time Frame: Measured through the 8th postoperative day ]
  • In-hospital mortality [ Time Frame: Measured through the 8th postoperative day ]
  • ICU length of stay (LOS) [ Time Frame: Measured through the 8th postoperative day ]
  • Hospital LOS [ Time Frame: Measured through the 8th postoperative day ]
  • Direct costs of hospital care [ Time Frame: Measured through the 8th postoperative day ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2006)
  • 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 (all measured through the 8th postoperative day)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
Official Title  ICMJE Aminocaproic Acid and Bleeding in Spinal Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Scoliosis
  • Kyphosis
  • Lordosis
  • Spondylitis
  • Spinal Stenosis
Intervention  ICMJE
  • Drug: Epsilon-Aminocaproic Acid (EACA)
    Participants will receive EACA intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
  • Drug: Placebo
    Participants will receive placebo intravenously during surgery and for 8 hours following surgery in the intensive care unit (ICU).
Study Arms  ICMJE
  • Experimental: 1
    Participants will receive either EACA.
    Intervention: Drug: Epsilon-Aminocaproic Acid (EACA)
  • Placebo Comparator: 2
    Participants will receive placebo.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2006)
182
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00320619
Other Study ID Numbers  ICMJE 360
K23HL070058-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sean Berenholtz, MD, MHS, Johns Hopkins Medical Institutions
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Berenholtz, MD, MHS Johns Hopkins University
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP