Trial Outcomes & Findings for Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO) (NCT NCT02887820)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

From time patient is placed on ECMO to 30-days post ECMO initiation

Results posted on

2025-05-31

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Arm All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Use of Thromboelastography (TEG) in Patient's Requiring Extracorporeal Membrane Oxygenation (ECMO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	47.2 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time	4 Participants

SECONDARY outcome

Timeframe: From the time patient is placed on ECMO to 30-days post ECMO initiation

Number of patients who required transfusions

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Number of Transfusions Required While on ECMO	9 Participants

SECONDARY outcome

Timeframe: From the time patient is placed on ECMO to 30-days post ECMO initiation

Number of patients who experienced bleeding while on ECMO

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus	11 Participants

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Average chest tube output

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Chest Tube Output and Overall Estimated Blood Loss	2692 ML Interval 0.0 to 8980.0

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Population: Data not collected-- the transfusion times are not well documented in the EMR. It is impossible to tell what time transfusions occurred. This data was not collected and the study status was changed to "terminated"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Population: Type of blood products administered is not well documented in the EMR. This data was not collected and the study status was changed to "terminated". DATA NOT COLLECTED, this information does not exist in the EMR. We did not anticipate this at the beginning of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Number of participants who required pump exchanges

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Pump Exchanges Required	4 Participants

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Population: Data not analyzed

NUmber of participants who required oxygenator exchanges while on ECMO

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Oxygenator Exchanges	3 Participants

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Number of participants with pump circuit clotting

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange)	2 Participants

SECONDARY outcome

Timeframe: From time patient is placed on ECMO until time to weaning from ECMO

Average time to ECMO removal

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Time to Weaning From/Removal of ECMO	19315 minutes Interval 2104.0 to 54090.0

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Number of participants

Outcome measures

Outcome measures
Measure	Pilot Arm n=15 Participants All subjects enrolled in the trial will be in the pilot group. These subjects will have traditional laboratory coagulation and blood transfusion tests (baseline arterial blood gas (ABG), complete blood count (CBC), fibrinogen, platelet count, aPTT, PT, anti-Xa, ACT), as well as thromboelastograph (TEG). Pertinent TEG results will include: heparinase-kaolin TEG maximum amplitude (MA) in millimeters (mm), heparinase-kaolin TEG r-time in seconds, heparinase-kaolin TEG alpha angle in degrees, and TEG functional fibrinogen (FLEV) MA in mm. Thromboelastograph: A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Need for Surgical Intervention for Hemorrhage	9 Participants

SECONDARY outcome

Timeframe: From time patient is placed on ECMO to 30-days post ECMO initiation

Population: This data is not well documented in the EMR. This data was not collected and the study status was changed to "terminated". DATA NOT COLLECTED. NO resources to data mine this information.

Outcome measures

Outcome data not reported

Adverse Events

Pilot Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Monroe

University of Pittsburgh

Phone: 412-623-6382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place