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Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) After Cardiac Surgery

This study is not yet open for participant recruitment.
Verified August 2011 by Rambam Health Care Campus
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01418521
First received: August 9, 2011
Last updated: August 16, 2011
Last verified: August 2011
History of Changes
  Purpose

The purpose of this randomized controlled trial in patients undergoing cardiac surgery is to show that a 3rd generation HES (Hydroxyethyl Starch) solution - Tetraspan® is as good as in terms of safety and effectiveness as the commonly used albumin based solution for volume replacement after the surgery.


Condition Intervention Phase
Elective Cardiac Surgery
 Drug: Balanced hydroxyethyl starch solution
Drug: Ringer- albumin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Effectiveness of a Balanced 3rd Generation HES Solution (Tetraspan®) Versus Albumin Solution for Volume Replacement in Patients After Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Chest tube drainage volume [ Time Frame: Total volume at the time of removal of drains (48 hours after surgery on average) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Volume of replacement fluids given after surgery at each group [ Time Frame: Summary of volume replacement at the time of discharge from ICU (48 hours after surgery on average) ] [ Designated as safety issue: No ]
  • In hospital - all cause mortality [ Time Frame: End of hospitalization (5 days postsurgery on average) ] [ Designated as safety issue: Yes ]
  • 30-days all cause mortality [ Time Frame: 30 days from surgery ] [ Designated as safety issue: Yes ]
  • Incidence of kidney injury as defined by RIFLE criteria [ Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days) ] [ Designated as safety issue: Yes ]
  • Incidence of coagulopathy as defined by prolonged PT\PTT and abnormal thromboelastogram not due to clotting inhibitors during hospitalization. [ Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days) ] [ Designated as safety issue: Yes ]
  • Volume of Transfused blood products during hospitalization postsurgery [ Time Frame: Duration of hospitalization after surgery (expected average duration of 5 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ringer-albumin
Patients receiving the standard care of ringer-albumin as volume replacement after cardiac surgery
 Drug: Ringer- albumin
Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery
Other Names:
  • HARTMANN Solution
  • Human albumin 20%- Zenalb
Experimental: Tetraspan
patients receiving a 3rd generation HES solution (tetraspan) for volume replacement after cardiac surgery
 Drug: Balanced hydroxyethyl starch solution
Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
Other Name: Tetraspan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed.
  • Male or Female subject, 18 years or older.
  • Any elective cardiac surgery

Exclusion Criteria:

  • Subjects with impaired liver function defined as an elevated level of ALT and AST over 100 U/L.
  • Hyperhydration states (e.g. pulmonary edema, congestive heart failure).
  • Renal failure with creatinine blood levels > 2.5 mg/dL or eGFR < 30 ml/min (calculated using the DMRD formula).
  • Oliguria (UO<0.5ml\kg\hr) or anuria (not related to hypovolemia) more than 12 hours.
  • Current Intracranial hemorrhage.
  • Current, hard to balance hyperkalemia.
  • Severe hypernatremia or severe hyperchloremia.
  • Known hypersensitivity to hydroxyethyl starch or to any of the excipients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418521

Contacts
Contact: Liran Shani, MD 972-8542631 l_shani@rambam.health.gov.il

Locations
Israel
Rambam health care campus Not yet recruiting
Haifa, Israel
Contact: Liran Shani, MD         l_shani@rambam.health.gov.il    
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Zvi Adler, MD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Zvi Adler, Rambam Health Care Campus, cardiac surgery department
ClinicalTrials.gov Identifier: NCT01418521     History of Changes
Other Study ID Numbers: RMB-0058.CTIL
Study First Received: August 9, 2011
Last Updated: August 16, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Cardiac surgery
Balanced 3rd generation Hydroxyethyl starch
Tetraspan
Ringer-albumin

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013