TEG-FF: Thromboelastography-derived Functional Fibrinogen Levels

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01992757
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Duration (Months): 21
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements

Condition or Disease	Intervention/Treatment	Phase
Focus of Study; Coagulation Status of Cardiac Surgery Patient; Reducing Excess Blood Transfusion

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass
• Study Start Date: Nov 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cardiac surgery with cardiopulmary bypass

Outcome Measures

Primary Outcome Measures

1. Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) [Change in FLEV from rewarming and after cardiopulmonary bypass]

   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.

Secondary Outcome Measures

1. Difference in Clauss Assay and FLEV [Clauss vs FLEV for rewarming and post-CPB]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective cardiac surgery patients who are undergoing primary cardiac surgery

Exclusion Criteria:

• Emergency surgery

• Re-operative cardiac surgery

• History of hypercoagulable state as defined in medical record

• Anticoagulated status at time of surgery

• Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Prakash A Patel, MD, University of Pennsylvania Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01992757
• Other Study ID Numbers: 818918
• First Posted: Nov 25, 2013
• Last Update Posted: Oct 3, 2018
• Last Verified: Nov 1, 2017

• Keywords provided by University of Pennsylvania: functional fibrinogen assay; cardiac surgery

Study Results

Participant Flow

Arm/Group Title	Cardiac Surgery With Cardiopulmary Bypass
Arm/Group Description	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.
Period Title: Overall Study
STARTED	51
COMPLETED	49
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Cardiac Surgery With Cardiopulmary Bypass
Arm/Group Description	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 Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 53.1%
>=65 years	23 46.9%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	63.1
Sex: Female, Male (Count of Participants)
Female	20 40.8%
Male	29 59.2%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)
Description	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.
Time Frame	Change in FLEV from rewarming and after cardiopulmonary bypass

Outcome Measure Data

Analysis Population Description

49 patients undergoing cardiac surgery with CPB.

Arm/Group Title	FLEV Difference During Rewarming & Post-cardiopulmonary Bypass
Arm/Group Description	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.
Measure Participants	49
Mean (95% Confidence Interval) [mg/dL]	-1.1

2. Secondary Outcome

Title	Difference in Clauss Assay and FLEV
Description	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.
Time Frame	Clauss vs FLEV for rewarming and post-CPB

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Clauss vs FLEV at Rewarming and Post-CPB
Arm/Group Description	All enrolled patients were in a single arm with multiple timepoints. Clauss assay and FLEV values were obtained at baseline, rewarming, and post-CPB. The secondary outcome was to compare the rewarming and post-CPB values of Clauss value to FLEV to determine if a significant difference exists.
Measure Participants	49
Mean Clauss vs FLEV difference at rewarming	120.6
Mean Clauss vs FLEV difference post-CPB	119.5

Adverse Events

Arm/Group Title	Cardiac Surgery With Cardiopulmary Bypass
Arm/Group Description	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.
All Cause Mortality
	Cardiac Surgery With Cardiopulmary Bypass
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Serious Adverse Events
	Cardiac Surgery With Cardiopulmary Bypass
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Cardiac Surgery With Cardiopulmary Bypass
	Affected / at Risk (%)	# Events
Total	0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.