Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions

NCT02540434 | Terminated Results

• 1 other identifier: 1408015402
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The study aligns with the strategic plan of New York-Presbyterian Hospital (NYPH) to reduce allogeneic blood product use and decrease unnecessary laboratory costs. One of the NYPH Quality and Patient Safety Goals for 2013 was to improve the appropriate use of transfusion guidelines and reduce unnecessary red blood cell (RBC) transfusions. Further, this study will help to answer whether RiaSTAP is a more effective product to treat bleeding than cryoprecipitate. In addition, this trial will provide investigators with preliminary data to apply for future federal funding opportunities, such as the National Heart Lung and Blood Institute sponsored R21 grant (PAR-13-025) that encourages research grant applications from investigators who propose to study research topics in blood banking and transfusion medicine aimed at improving the safety and availability of the blood supply and the practice of transfusion medicine. The investigators anticipate future follow-on studies further investigating fibrinogen concentrate and other similar therapeutics in other perioperative populations, such as in postpartum hemorrhage or surgical ICU settings. Finally, this study involves the use of a safer therapeutic, fibrinogen concentrate, to improve patient care and patient safety. This product does not require the time-intensive process of thawing; therefore, delays in patient care can be avoided by having the product readily available in the OR.

Conditions

Coagulopathy

Keywords

Hypofibrinogenemia; ROTEM; Cardiac Surgery; Concentrated Fibrinogen

Outcome Measures

Primary Outcomes (1)

• Intraoperative Blood Transfusion Total

  The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention.

  Procedure length, the average for participants is approximately 6 hours

Secondary Outcomes (13)

• 24-hour Blood Transfusion Total

  24 hours

• Fibrinogen Repletion

  Procedure length, the average for participants is approximately 6 hours

• Incidence of Zero Transfusions

  24 hours

• Correction of Microvascular Bleeding

  ~30 min intraoperatively

• CTICU Length of Stay

  Length of Hospital Stay, the average for participants is approximately 7 days

Study Arms (2)

RiaSTAP Arm

ACTIVE COMPARATOR

Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.

Device: ROTEM; Drug: RiaSTAP

Cryopreciptiate Arm

ACTIVE COMPARATOR

Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.

Device: ROTEM; Other: Cryoprecipitate

Interventions

ROTEM DEVICE

ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.

Also known as: ROTEM delta

Cryopreciptiate Arm; RiaSTAP Arm

Cryoprecipitate OTHER

Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate

Cryopreciptiate Arm

RiaSTAP DRUG

Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen

Also known as: Concentrated Fibrinogen

RiaSTAP Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects age 18 and older who have given written informed consent
• Undergoing cardiac surgery cardiopulmonary bypass (CBP) at Weill Cornell Medical Center

You may not qualify if:

• Subjects on anticoagulation medications including:
• Clopidogrel, ticagrelor, prasugrel with platelet function analyzer-100 assay closure time (CT) prolonged greater than 15%
• Last doses of dabigatran, rivaroxaban, apixaban within 72 hours
• Warfarin with international normalized ratio (INR) greater than 1.5
• Positive pregnancy test, pregnancy or lactation
• Thrombocytopenia: platelet count less than 100,000 u/L
• Emergency procedures
• Proof or suspicion of a congenital or acquired coagulation disorder (e.g. von Willebrand Factor or via severe liver disease)
• Participation in another randomized clinical trial

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders; Afibrinogenemia

Interventions

cryoprecipitate coagulum; Fibrinogen

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors

Results Point of Contact

• Title: Michele Steinkamp
• Organization: Weill Cornell Medicine

mls9004@med.cornell.edu

2127462953

Study Officials

• Nikolaos J Skubas, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: September 4, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 15, 2019
• Results First Posted: May 12, 2017

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)