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Open Label Use Of RiaStap During Aortic Reconstruction

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ClinicalTrials.gov Identifier: NCT01300286
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : June 16, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Duke University

Brief Summary:
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 or disease Intervention/treatment Phase
Coagulopathic Bleeding Drug: RiaSTAP Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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