RiaSTAP vs. Conventional Transfusion in Patients Having Heart Valve Surgery
| Status: | Terminated |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 6/23/2018 |
| Start Date: | January 2011 |
| End Date: | May 2013 |
RiaSTAP vs. Conventional Transfusion for Patients Undergoing Valve Replacement Surgery: RiaCT
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.
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.
Platelet and plasma transfusion remain in the mainstay hemostatic therapy for perioperative
bleeding. Several studies indicate that acquired fibrinogen deficiency can be the primary
cause of bleeding after cardiac surgery. The aim of the study is to compare hematologica and
transfusion profiles between the first-line fibrinogen replacement and platelet transfusion
in post-cardiac surgical bleeding. In this prospective randomized, open-lable study, 20 adult
patients undergoing valve replacement or repair, and fulfilling preset visual bleeding scale
(0=excellent hemostasis; 1=oozing; 2=moderate bleeding; 3=severe bleeding from multiple
bleeding sites) are randomized to 4 g of fibrinogen or 1 unit of apheresis platelet
transfusion. After the initial randomized intervention, additional transfusions are given in
the presence of bleeding (>200 ml/hour) according to the institutional practie as follows; 1
apheresis platelet unit if platelet count is less than 100 x 10^9 /L, 2 units of plasma if
international normalized ratio is >1.6, or 10 units of cryoprecipitate if fibrinogen level is
<200 mg/dL. Primary endpoints include hemostatic condition in the surgical field and 24-hour
hemostatic product usage. Hematologica data, clinical outcome, and safety date are collected
up to the 28th day postoperative visit.
bleeding. Several studies indicate that acquired fibrinogen deficiency can be the primary
cause of bleeding after cardiac surgery. The aim of the study is to compare hematologica and
transfusion profiles between the first-line fibrinogen replacement and platelet transfusion
in post-cardiac surgical bleeding. In this prospective randomized, open-lable study, 20 adult
patients undergoing valve replacement or repair, and fulfilling preset visual bleeding scale
(0=excellent hemostasis; 1=oozing; 2=moderate bleeding; 3=severe bleeding from multiple
bleeding sites) are randomized to 4 g of fibrinogen or 1 unit of apheresis platelet
transfusion. After the initial randomized intervention, additional transfusions are given in
the presence of bleeding (>200 ml/hour) according to the institutional practie as follows; 1
apheresis platelet unit if platelet count is less than 100 x 10^9 /L, 2 units of plasma if
international normalized ratio is >1.6, or 10 units of cryoprecipitate if fibrinogen level is
<200 mg/dL. Primary endpoints include hemostatic condition in the surgical field and 24-hour
hemostatic product usage. Hematologica data, clinical outcome, and safety date are collected
up to the 28th day postoperative visit.
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 coronary artery bypass graft (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
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