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RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery (RiaCT)

This study is currently recruiting participants.
Verified August 2012 by Emory University
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Gautam Sreeram, Emory University
ClinicalTrials.gov Identifier:
NCT01283321
First received: January 24, 2011
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

Heart surgery involving valve replacement often involves the use of the heart-lung machine for over 90 minutes, and bleeding tendency is frequently seen. Conventionally, platelet transfusion has been the primary therapy to treat bleeding after this type of procedure. More recently, perioperative supplementation of purified fibrinogen (RiaSTAP, CSL Behring) was shown to reduce bleeding and blood product use (plasma or platelets) after heart surgery. The objective of this trial is to demonstrate the clinical equivalency and economic utility of using fibrinogen concentrate, RiaSTAP for the mitigation of post-operative bleeding in patients in lieu of platelet transfusion.

Purified fibrinogen concentrate has been approved by FDA, and it has been used for the treatment of acute bleeding episodes in patients with low fibrinogen due to hereditary causes (e.g., afibrinogenemia). Compared to the transfusion of platelets which may be associated with volume overload, bacterial/viral infection, immunological effects and excess blood clotting, purified fibrinogen has several advantages. First, it contains no liquid plasma allowing for low volume infusion. Several viral inactivation/reduction steps are used to prepare the fibrinogen concentrate, increasing its viral safety. No antibodies or white blood cells are contained in the fibrinogen concentrate; therefore transfusion reactions are rare. Although platelet transfusion is widely used after heart surgery, there has been no randomized study to endorse this practice. In this study, patients undergoing heart valve replacement will be randomized to receive either platelet (1 unit) transfusion or fibrinogen concentrate (4g) after heparin anticoagulation is reversed. Subjects will be treated only if there is evidence of significant microvascular bleeding. Fifteen minutes after the initial treatment, subjects will be reevaluated for bleeding. If bleeding continues, subjects will be treated with blood transfusion per institutional standard of care.

The primary endpoints for this study are the hemostatic condition of the surgical field and 24-hour total of blood product transfusion.


Condition Intervention Phase
Heart Valve Disease With or Without Coronary Artery Disease
 Drug: Human fibrinogen concentrate
Other: apheresis platelets
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RiaSTAP vs. Conventional Transfusion for Patients Undergoing Valve Replacement Surgery: RiaCT

Resource links provided by NLM:

Drug Information available for: Fibrinogen
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pattern of coagulation disturbance in the conventional treatment(platelet concentrate) and fibrinogen concentrate groups [ Time Frame: intra-operatively and up to 24 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients in the fibrinogen group in whom transfusion of fresh frozen plasma or platelet concentrate is required during or after surgery [ Time Frame: Operative period ] [ Designated as safety issue: No ]
  • Units of FFP transfused-during surgery and up to 24 hours after surgery [ Time Frame: Peri-operative period ] [ Designated as safety issue: No ]
  • Units of platelets and allogeneic red cells transfused- during surgery and up to 24 hours after surgery [ Time Frame: Peri-operative period ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: Operative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A: RiaSTAP Drug: Human fibrinogen concentrate
4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
Other Name: RiaSTAP
Active Comparator: Group B: apheresis platelets Other: apheresis platelets
A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Age >17 and < 86 years

  • Patients undergoing planned cardiopulmonary bypass (CPB) for:

    1. combined coronary artery bypass grafting and valve replacement/repair surgery
    2. single valve replacement surgery
    3. mitral valve repair surgery

    3. or double valve surgery (aortic and mitral)

  • Presence of clinically relevant microvascular bleeding after protamine administration (hemostasis assessment score of 2-3)

  • Patients should fulfill the following parameters prior to the study intervention:

    • Body temperature > 35.0°C
    • Blood pH > 7.2
    • Hb > 7.0 mg/dL
    • Activated clotting time (ACT) < 155 seconds
    • CPB time > 60 minutes

Exclusion Criteria:

  • Replacement of aorta
  • Planned valve replacement without median sternotomy
  • Previous valve replacement surgery (previous CABG acceptable)
  • History or suspicion of a congenital or acquired coagulation disorder such as hemophilia, von Willebrand disease, and liver disease
  • Hemodialysis dependent renal failure
  • Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
  • Known allergy/anaphylaxis to fibrinogen concentrate or apheresis platelet units
  • Clopidogrel administration within 5 days of surgery
  • Coumadin (warfarin) administration within 5 days of surgery
  • Participation in another clinical study in the 4 weeks preceding surgery
  • Any indication that a potential subject did not comprehend the study restrictions, procedures, or consequences therein an informed consent cannot be convincingly given
  • Life expectancy less than 48 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283321

Contacts
Contact: Kathy F Egan, BSN, RN 404-727-8463 kfegan@emory.edu

Locations
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
CSL Behring
Investigators
Principal Investigator: Gautam Sreeram, MD Emory University
  More Information

No publications provided

Responsible Party: Gautam Sreeram, MD, Emory University
ClinicalTrials.gov Identifier: NCT01283321     History of Changes
Other Study ID Numbers: RiaCT 2010
Study First Received: January 24, 2011
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Hemostasis
Cardiopulmonary bypass (heart-lung machine)
Fibrinogen
platelet

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Valve Diseases
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013