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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT00320619
• Date of registration: 28/04/2006
• Prospective Registration: No
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
• Scientific title: Aminocaproic Acid and Bleeding in Spinal Surgery
• Date of first enrolment: September 2000
• Target sample size: 182
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00320619
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Sean Berenholtz, MD, MHS
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kyphosis

Spinal Stenosis

Scoliosis

Spondylitis

Lordosis

Intervention(s)

Drug: Epsilon-Aminocaproic Acid (EACA)

Drug: Placebo

Primary Outcome(s)

Number of allogenic blood units transfused [Time Frame: Measured through the 8th postoperative day]

Secondary Outcome(s)

Potential surgical complications [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 EACA [Time Frame: Measured through the 8th postoperative day]

Potential complications of transfusion [Time Frame: Measured through the 8th postoperative day]

Direct costs of hospital care [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]

Duration of mechanical ventilation [Time Frame: Measured through the 8th postoperative day]

Intraoperative and postoperative blood loss [Time Frame: Measured through the 8th postoperative day]

Hospital LOS [Time Frame: Measured through the 8th postoperative day]

Secondary ID(s)

360

K23HL070058-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors