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Trial record 19 of 32 for:    Craniosynostosis

Efficacy of Amicar for Children Having Craniofacial Surgery

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ClinicalTrials.gov Identifier: NCT02229968
Recruitment Status : Active, not recruiting
First Posted : September 3, 2014
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Srijaya K. Reddy, MD, MBA, Children's Research Institute

Brief Summary:

The purpose of this study is to determine whether Amicar (ε-aminocaproic acid) is effective in reducing blood loss in children undergoing craniofacial reconstruction surgery.

The investigators hypothesize that Amicar will decrease intraoperative blood loss and decrease the need for perioperative blood product administration in children undergoing craniofacial surgery.


Condition or disease Intervention/treatment Phase
Craniosynostosis Drug: Amicar (ε-aminocaproic acid) Drug: normal saline Phase 2

Detailed Description:

Craniosynostosis is a condition in which there is premature fusion of one or more of the sutures between the bones of the skull. Premature fusion of sutures in the skull limits the ability of the cranial vault to expand to accommodate the rapidly growing brain in infancy and early childhood and leads to bony deformation. Left uncorrected, craniosynostosis may adversely impact both neurologic and psychosocial development and in some cases, can result in high intracranial pressure and blindness.

Craniofacial (CF) reconstructive surgery is performed in young children with craniosynostosis to improve physical appearance, prevent functional neurologic disturbances, and enhance psychosocial development. Due to the complexities of the surgery as well as the young age and size of the patients, CF reconstruction carries potential life threatening risks and can result in significant morbidity. Reported complications include massive intraoperative hemorrhage, intraoperative cardiac arrest, transfusion-related reactions, venous air embolism, hypotension, coagulopathy, bradycardia, postoperative seizures, surgical site infections, facial swelling with airway compromise, and unplanned postoperative mechanical ventilation. The most severe and most common perioperative issues relate to the rate and extent of blood loss.

Fibrinolysis, which impairs adequate hemostasis, has been shown to occur in children during CF reconstruction. This most certainly contributes to the magnitude of blood loss in these types of operations. Thus, targeting this defect in clot hemostasis with the use of antifibrinolytics is a reasonable therapeutic approach.

Amicar (ε-aminocaproic acid) is a synthetic lysine analog that blocks the lysine binding sites on plasminogen, resulting in antifibrinolytic activity through inhibition of plasmin formation. We have chosen to study Amicar in this clinical context for a number of reasons. First, major hemorrhage continues to be a significant perioperative issue in this cohort. Secondly, Amicar is commonly and safely administered to children undergoing other types of high-risk surgery (i.e., spinal fusion surgery and open heart surgery). In addition, Amicar is inexpensive and easily administered, making it a viable and novel therapeutic option if shown to be effective for this type of surgery.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of ε-Aminocaproic Acid (EACA) in Children Undergoing Craniofacial Reconstruction Surgery
Study Start Date : October 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Amicar (ε-aminocaproic acid)
Treatment group 1: Amicar 100 mg/kg (0.4 mL/kg) IV loading dose, followed by an intraoperative continuous infusion at 40 mg/kg/hr (0.16 mL/kg/hr) to be continued until skin closure.
Drug: Amicar (ε-aminocaproic acid)
Other Names:
  • Amicar
  • 6-aminohexanoic acid
  • epsilon aminocaproic acid
Placebo Comparator: normal saline
Treatment group 2: Equal volume of normal saline (placebo control) at the same rate as treatment group 1.
Drug: normal saline
Other Names:
  • normal saline 0.9%
  • placebo
  • placebo control



Primary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: within the first 72 hours after surgery ]
    As estimated blood loss is known to be inaccurate in this setting, mean intraoperative blood loss (in mL/kg) will be calculated using a formula previously described in this population.


Secondary Outcome Measures :
  1. Blood donor exposure [ Time Frame: within the first 30 days after surgery ]
    To establish that intraoperative administration of Amicar decreases perioperative blood donor exposure and need for transfusion following craniofacial reconstructive surgery



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Ages Eligible for Study:   2 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any child diagnosed with craniosynostosis in need of surgical repair
  • Males and females between the ages of 2 - 36 months (minorities will be included)
  • Surgical procedure involving complex craniofacial reconstruction and craniotomy
  • Written informed consent from parent/guardian

Exclusion Criteria:

  • Subjects with known or suspected hypersensitivity reaction to Amicar or history of prior Amicar exposure
  • Presence or prior history of a known coagulation disorder or hypercoagulable state
  • Preoperative laboratory values that indicate clinically significant hematologic disease (hemoglobin, platelet count, prothrombin time, or partial thromboplastin time outside of normal range)
  • Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
  • Subjects with a prior history of a thrombotic event
  • History of renal malformation
  • Presence of hematuria
  • History of abnormal renal function - serum creatinine or blood urea nitrogen (BUN) value greater than 1.5 times the upper limit of the normal range
  • Craniofacial reconstruction surgery performed in conjunction with an additional surgical procedure associated with blood loss
  • Subjects who have been previously enrolled in this protocol may not be enrolled again

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229968


Locations
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Srijaya K. Reddy, MD, MBA
Investigators
Principal Investigator: Srijaya K Reddy, MD, MBA Children's Research Institute

Publications:
Responsible Party: Srijaya K. Reddy, MD, MBA, Assistant Professor of Anesthesiology and Pediatrics, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02229968     History of Changes
Other Study ID Numbers: PRO00004263
First Posted: September 3, 2014    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Srijaya K. Reddy, MD, MBA, Children's Research Institute:
craniosynostosis
craniofacial
amicar
epsilon aminocaproic acid
ε-aminocaproic acid

Additional relevant MeSH terms:
Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities
Aminocaproic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants