Trial Outcomes & Findings for Thromboelastography-derived Functional Fibrinogen Levels (NCT NCT01992757)

Results Overview

FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

Change in FLEV from rewarming and after cardiopulmonary bypass

Results posted on

2018-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Cardiac Surgery With Cardiopulmary Bypass Patients over the age of 18 years undergoing cardiac surgery requiring CPB. Patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
Overall Study STARTED	51
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Cardiac Surgery With Cardiopulmary Bypass Patients over the age of 18 years undergoing cardiac surgery requiring CPB. Patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
Overall Study 2 patients excluded due to FFP given.	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cardiac Surgery With Cardiopulmary Bypass n=49 Participants patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=49 Participants
Age, Categorical >=65 years	23 Participants n=49 Participants
Age, Continuous	63.1 years n=49 Participants
Sex: Female, Male Female	20 Participants n=49 Participants
Sex: Female, Male Male	29 Participants n=49 Participants
Region of Enrollment United States	49 participants n=49 Participants

PRIMARY outcome

Timeframe: Change in FLEV from rewarming and after cardiopulmonary bypass

Population: 49 patients undergoing cardiac surgery with CPB.

FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.

Outcome measures

Outcome measures
Measure	FLEV Difference During Rewarming & Post-cardiopulmonary Bypass n=49 Participants All enrolled patients were in a single arm with multiple timepoints. FLEV values were obtained at baseline, rewarming, and post-CPB. The primary outcome was to compare the rewarming and post-CPB values to determine if a significant difference exists.
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)	-1.1 mg/dL Interval -25.8 to 23.6

SECONDARY outcome

Timeframe: Clauss vs FLEV for rewarming and post-CPB

Population: 49 patients undergoing cardiac surgery with CPB. The measure is the difference of the FLEV and the Clauss assay (i.e. FLEV minus Clauss since the FLEV is consistently higher).

This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.

Outcome measures

Outcome measures
Measure	FLEV Difference During Rewarming & Post-cardiopulmonary Bypass n=49 Participants All enrolled patients were in a single arm with multiple timepoints. FLEV values were obtained at baseline, rewarming, and post-CPB. The primary outcome was to compare the rewarming and post-CPB values to determine if a significant difference exists.
Difference in Clauss Assay and FLEV Mean Clauss vs FLEV difference at rewarming	120.6 mg/dL Interval 104.1 to 137.1
Difference in Clauss Assay and FLEV Mean Clauss vs FLEV difference post-CPB	119.5 mg/dL Interval 101.7 to 137.4

Adverse Events

Cardiac Surgery With Cardiopulmary Bypass

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rupa Chowdary

University of Pennsylvania Hospital

Phone: 215-615-4105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place