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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Hydroxyethyl Starch Derivatives
Pharmaceutical Solutions
Blood Substitutes
Hematologic Agents
Pharmacologic Actions
Plasma Substitutes
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014