Coagulopathy Clinical Trial
Official title:
Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions (TOP-CLOT)
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.
All eligible subjects undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) at
New York Presbyterian Hospital-Weill Cornell Medical College will be invited to participate.
Consenting subjects will be enrolled and treated according to the protocol. Study
investigators anticipate that by consenting all eligible cardiovascular surgical subjects,
investigators will not omit the results of subjects who may present with microvascular
bleeding after CPB. It is well known that microvascular bleeding occurs more often in
reoperations or complex, open cardiac procedures, such as coronary revascularization and
valve repair/replacement, or aortic replacements under deep hypothermic circulatory arrest.
Enrolled subjects will receive intraoperative anesthetic, anticoagulation, laboratory
testing, and hemodynamic management according to WCMC standards of practice. The need for
blood products, including fibrinogen supplementation (CRYO/FIB), will be assessed using a
point-of-care (ROTEM) based transfusion algorithm (Appendix A) to ensure consistency and
accuracy of treatment. The cardiac anesthesiologists and surgeons are currently using the
ROTEM algorithm for the treatment of bleeding during cardiovascular surgery with CPB as part
of routine clinical practice at WCMC. The algorithm will have been in place for greater than
9 months prior to study initiation. Randomization will occur in the blood bank when study
product (CRYO/FIB) is requested to treat intraoperative acquired hypofibrinogenemia (based on
ROTEM tracings). Transfusion of the randomized study product (CRYO/FIB), however, will only
occur when the surgeon declares the presence of microvascular bleeding. Surgeons will be
blinded to the subject's ROTEM results and randomized study arm. Intraoperative
anesthesiologists will not be blinded as the two products require different preparation and
administration techniques and cannot be blinded easily.
Once the subject is randomized to their study intervention they will receive that product at
all subsequent points during the procedure when fibrinogen replacement is required. If
microvascular bleeding occurs and there is no indication by the ROTEM algorithm to administer
CRYO/FIB, the subject will revert to standard of care treatment guided by ROTEM or
traditional laboratory testing. The subject will not be randomized in the study. In the case
of abnormal ROTEM parameters but no clinical evidence of microvascular bleeding as evaluated
by the cardiac surgeon, the subject will continue to be monitored carefully for bleeding for
the remainder of the procedure. If non-surgical bleeding is subsequently observed prior to
chest closure and the consensus is that fibrinogen is needed based on ROTEM results (FIBTEM
A10 less than or equal to 10 mm), the subject will be treated with their randomized study
product according to the algorithm. Following completion of the procedure, postoperative
coagulation management will be according to standard practice and guided by standard
laboratory testing, when possible. Unless persistent bleeding is noted, all subjects will
receive aspirin (300 mg per rectum) 6 hours postoperatively. Subjects with mechanical or
mitral tissue valves will be anticoagulated with warfarin (no heparin bridge) starting on
postoperative day two (POD#2). Any subjects experiencing significant arrhythmias (e.g. atrial
fibrillation in the perioperative setting) will also be anticoagulated with warfarin.
Pharmacologic deep vein thrombosis (DVT) prophylaxis will follow the usual standard of care.
Subjects enrolled, randomized, and transfused study product will be observed until hospital
discharge (total observation time). Research staff from the Department of Anesthesiology will
collect outcomes data, including transfused blood products, laboratory results, evidence of
perioperative thrombosis or infection, returns to the OR, length of stay, and mortality using
case report forms reports and enter all collected data into a secure REDCap database.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT01912547 -
Thromboelastography During Surgery for Malignant Pleural Mesothelioma
|
Phase 0 | |
Completed |
NCT03674684 -
ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
|
||
Recruiting |
NCT05874843 -
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
|
N/A | |
Withdrawn |
NCT04705701 -
Comparing Post Cardiac Surgery Outcomes in ESRD Patient's With Early Dialysis Versus Standard Care
|
N/A | |
Not yet recruiting |
NCT04515420 -
The Influence of Noradrenaline on Coagulation and Fibrinolysis in Severe Isolated Brain Injury
|
||
Completed |
NCT01598831 -
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
|
Phase 3 | |
Completed |
NCT04580563 -
Study Assessing Efficacy of Plasmatherapy in Septic Shock-induced Coagulopathy: Feasibility Study
|
N/A | |
Withdrawn |
NCT04274699 -
Clinical Evaluation of the Hemosonics Quantra® Coagulation Monitor in Liver and Multivisceral Transplantation
|
||
Completed |
NCT02203968 -
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
|
Phase 1/Phase 2 | |
Unknown status |
NCT01854476 -
Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze
|
Phase 2/Phase 3 | |
Completed |
NCT00816127 -
Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction
|
N/A | |
Active, not recruiting |
NCT02926274 -
Transfusion Using Stored Whole Blood
|
N/A | |
Completed |
NCT05295693 -
Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study
|
||
Not yet recruiting |
NCT04582188 -
The Early Coagulopathy for the Prognosis in Sepsis
|
||
Recruiting |
NCT04528888 -
Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection
|
Phase 3 | |
Recruiting |
NCT05449834 -
Fibrinogen Early In Severe Trauma StudY II
|
Phase 3 | |
Withdrawn |
NCT04435015 -
The Utility of Camostat Mesylate in Patients With COVID-19 Associated Coagulopathy (CAC) and Cardiovascular Complications
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04115722 -
Coagulation Parameters in IBD Patients
|
||
Completed |
NCT01228058 -
A Prospective Evaluation of Thromboelastography for Identifying Coagulopathy in Severely Injured Patients
|
N/A | |
Active, not recruiting |
NCT04128488 -
Effects of Gender-Affirming Hormone Therapy Among Transgender Women
|