Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
|ClinicalTrials.gov Identifier: NCT00813904|
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Blood Loss, Surgical||Biological: rThrombin, 1000 IU/mL||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis|
|Study Start Date :||January 2009|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
|Experimental: rThrombin, 1000 IU/mL||
Biological: rThrombin, 1000 IU/mL
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.
Other Name: RECOTHROM
- Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 [ Time Frame: At baseline and Day 29 ]Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.
- Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation [ Time Frame: Baseline through Day 29, continuously ]An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
- Number of Participants With AEs by Maximum Severity [ Time Frame: Baseline to Day 29, continuously ]An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813904
|United States, Arizona|
|Tuscon Orthopaedic Institute|
|Tuscon, Arizona, United States, 85712|
|Principal Investigator:||Neil Singla, MD||Lotus Clinical Research|