Trial Outcomes & Findings for Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions (NCT NCT02540434)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Procedure length, the average for participants is approximately 6 hours

Results posted on

2019-01-15

Participant Flow

All subjects undergoing cardiac surgery requiring cardiopulmonary bypass at Weill Cornell Medicine who dont meet exclusion criteria will be invited to participate prior to surgery. They will be recruited after admission to the hospital the day before surgery. If the subject consents to participate, they will be enrolled. Not all will be randomized.

Enrolled subjects will have initial blood sample taken for baseline ROTEM in the beginning of surgery. During rewarming, the next ROTEM will be run to assess for a FIBTEM A10 \< 10. If It is less than/equal to 10, subject will be randomized. If microvascular bleeding is detected subject will get intervention. Note: only 2 subjects were randomized.

Participant milestones

Participant milestones
Measure	RiaSTAP Arm 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. ROTEM: 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. RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen	Cryopreciptiate Arm Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. 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 curve. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RiaSTAP Arm n=1 Participants 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. ROTEM: 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. RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen	Cryopreciptiate Arm n=1 Participants Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. 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 curve. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Procedure length, the average for participants is approximately 6 hours

Population: Only 2 subjects out of total enrolled were randomized. Due to this only 2 subjects being randomized and the study being terminated before completion, no data analysis was done to assess the primary outcome. Therefore there is no measurable data for the mean and SD in either arm.

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