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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR AMICAR

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Clinical Trials for Amicar

Trial ID Title Status Sponsor Phase Summary
NCT00617955 Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates Completed State University of New York - Upstate Medical University N/A The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The result was a power of 81.7%.
NCT00912119 Amicar Pharmacokinetics of Children Having Craniofacial Surgery Completed Children's Anesthesiology Associates, Ltd. Phase 1 Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.
NCT00912119 Amicar Pharmacokinetics of Children Having Craniofacial Surgery Completed Thomas B. and Jeannette E. Laws McCabe Fund Pilot Award Phase 1 Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.
NCT00912119 Amicar Pharmacokinetics of Children Having Craniofacial Surgery Completed Paul Stricker Phase 1 Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region to repair cranial vault and facial deformities. The surgery is extensive, often requiring wide scalp dissections and multiple osteotomies and has been associated with significant morbidity. Some of the most severe and commonly seen problems are associated with the rate and extent of blood loss. Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of fibrinolysis, reduces transfusion requirements in children undergoing procedures on cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for scoliosis (1-6). Before controlled studies to assess efficacy of EACA in a craniofacial surgical population can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal dosing strategy. PK data exist for EACA in children undergoing operations on CPB and hypothermia. The aim of this study is to determine the pharmacokinetics of EACA in infants and children undergoing craniofacial reconstruction procedures.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Amicar

Condition Name

Condition Name for Amicar
Intervention Trials
Craniosynostosis 2
Intracerebral Hemorrhage 1
Hip Arthritis 1
Hematological Malignancies 1
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Condition MeSH

Condition MeSH for Amicar
Intervention Trials
Craniosynostoses 2
Aortic Diseases 1
Osteoarthritis 1
Hemorrhage 1
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Clinical Trial Locations for Amicar

Trials by Country

Trials by Country for Amicar
Location Trials
United States 8
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Trials by US State

Trials by US State for Amicar
Location Trials
Pennsylvania 2
District of Columbia 1
Georgia 1
North Carolina 1
California 1
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Clinical Trial Progress for Amicar

Clinical Trial Phase

Clinical Trial Phase for Amicar
Clinical Trial Phase Trials
Phase 4 3
Phase 2 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Amicar
Clinical Trial Phase Trials
Completed 5
Recruiting 3
Suspended 1
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Clinical Trial Sponsors for Amicar

Sponsor Name

Sponsor Name for Amicar
Sponsor Trials
Thomas B. and Jeannette E. Laws McCabe Fund Pilot Award 1
Stanford University 1
Children's Anesthesiology Associates, Ltd. 1
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Sponsor Type

Sponsor Type for Amicar
Sponsor Trials
Other 14
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Serving hundreds of leading biopharmaceutical companies globally:

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