Open Label Use Of RiaStap During Aortic Reconstruction

This study has been completed.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01300286
First received: January 9, 2011
Last updated: May 15, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    Fibrinogen levels will be assessed only at the timepoints listed in the timeframe and for a maximum of 24 hours.


Secondary Outcome Measures:
  • Total Blood Product Units Administered. [ Time Frame: Operating room admission thru 48 hour . ] [ Designated as safety issue: No ]
    As a secondary outcome we will record the total number of blood products administered over a 48 hour period.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 9, 2011
Results First Received: January 16, 2014
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014