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Open Label Use Of RiaStap During Aortic Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01300286
First Posted: February 21, 2011
Last Update Posted: December 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Duke University
  Purpose
The overall purpose of this study is to administer fibrinogen concentrate (RiaSTAP, CSL Behring, Marburg, Germany) with the goal of treating coagulopathic bleeding by improving hemostasis thereby reducing overall blood product transfusion after separation from cardiopulmonary bypass following aortic reconstructive surgery. With the current sample size this is a pilot study and in effect will determine the fibrinogen level response to fibrinogen concentrate administered during aortic reconstructive surgery. It will be underpowered to detect reduction in bleeding but comparison to historical controls will be included as a secondary outcome.

Condition Intervention Phase
Coagulopathic Bleeding Drug: RiaSTAP Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Use Of RiaStap During Aortic Reconstruction

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Fibrinogen Level Change [ Time Frame: Anesthesia Induction (Baseline), Pre RiaSTAP (est. 4 hr after baseline), Post RiaSTAP (est: 10 minutes after RiaSTAP administered), ICU Admission (est. 6 hours after baseline), 24 Hour post op (est: 24-30 hr after baseline) ]
    Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.


Secondary Outcome Measures:
  • Packed Red Blood Cell Transfusion [ Time Frame: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline) ]
  • Fresh Frozen Plasma Transfusion [ Time Frame: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline) ]
  • Platelet Transfusion [ Time Frame: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline) ]
  • Cryoprecipitate Transfusion [ Time Frame: Anesthesia Induction (Baseline), after CPB, ICU Admission (est. 6 hours after baseline) to post op day 2 (est: 30- 54 hr after baseline) ]

Enrollment: 23
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RiaSTAP
One time dose of 70 mg/kg will be administered intravenously.
Drug: RiaSTAP
One time dose of 70 mg/kg will be administered intravenously.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective, adult aortic reconstruction involving a hemi-arch replacement at DUMC.

Exclusion Criteria:

  • Concomitant procedures such as CABG , stents (within the last 3 years), refusal of blood transfusion, recent MI (within the last 3 months), pregnancy, INR > 1.1, platelet inhibitor drugs within 5 days of surgery (aspirin 325 mg within 48 hours of surgery), platelet count < 150,000, age <18 years, inability to obtain written informed consent, known coagulopathy including a history of recent coumadin therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300286


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
CSL Behring
Investigators
Principal Investigator: Ian Welsby, MD Duke University
  More Information

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01300286     History of Changes
Other Study ID Numbers: Pro00024305
First Submitted: January 9, 2011
First Posted: February 21, 2011
Results First Submitted: January 16, 2014
Results First Posted: June 16, 2014
Last Update Posted: December 25, 2014
Last Verified: January 2014


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