Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Terminated
inVentiv Health Clinical
Phase 4
2015-02-05
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of
Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia
in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at
approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over
a period of 19 months, and the study population will consist of at least 60 male and female
pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal,
orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25)
in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6
years to 12 years) cohorts.
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Terminated
Kedrion S.p.A.
Phase 4
2015-02-05
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of
Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia
in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at
approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over
a period of 19 months, and the study population will consist of at least 60 male and female
pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal,
orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25)
in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6
years to 12 years) cohorts.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
