Coagulopathy Clinical Trial
— TOP-CLOTOfficial title:
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions (TOP-CLOT)
NCT number | NCT02540434 |
Other study ID # | 1408015402 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | December 2017 |
Verified date | December 2018 |
Source | Weill Medical College of Cornell University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | December 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. All subjects age 18 and older who have given written informed consent 2. Undergoing cardiac surgery cardiopulmonary bypass (CBP) at Weill Cornell Medical Center Exclusion Criteria: 1. 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 2. Positive pregnancy test, pregnancy or lactation 3. Thrombocytopenia: platelet count less than 100,000 u/L 4. Emergency procedures 5. Proof or suspicion of a congenital or acquired coagulation disorder (e.g. von Willebrand Factor or via severe liver disease) 6. Participation in another randomized clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medical College | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 24-hour Blood Transfusion Total | Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end | 24 hours | |
Secondary | Fibrinogen Repletion | Fibrinogen repletion as measured by ROTEM FIBTEM >10mm after study product administration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | Procedure length, the average for participants is approximately 6 hours | |
Secondary | Incidence of Zero Transfusions | Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | 24 hours | |
Secondary | Correction of Microvascular Bleeding | Difference in surgeon's assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | ~30 min intraoperatively | |
Secondary | CTICU Length of Stay | Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Hospital Length of Stay | Number of days subject spends in the hospital from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Thrombosis and Transfusion Reactions | Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Infection and Respiratory Failure | Incidence of any infection or respiratory failure from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Blood Loss | Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume). Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Length of Hospital Stay, the average for participants is approximately 7 days, | |
Secondary | Incidence of Re-exploration | Incidence of subjects requiring a return to the OR for re-exploration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Mortality Rate | Rate of hospital death during initial hospital admission. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment | Length of Hospital Stay, the average for participants is approximately 7 days | |
Secondary | Correlation of Laboratory and ROTEM Data | Correlation of fibrinogen, von Willebrand Factor (vWF), and factor VIII levels measured in traditional lab with intraoperative ROTEM parameters. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Procedure length, the average for participants is approximately 6 hours | |
Secondary | Time to Product Administration | Time from request to administration of study product. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. | Procedure length, the average for participants is approximately 6 hours |
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