Heart Disease, Lung Disease
Conditions
Keywords
ECMO, TEG
Brief summary
This is a pilot study that seeks to evaluate the feasibility and safety of using a TEG algorithm in addition to traditional laboratory tests to guide transfusion and coagulation management of ECMO patients.
Detailed description
All adult patients requiring ECMO will be considered for the trial, with a target enrollment of 50 participants over a two-year period. For each enrolled participant, a TEG transfusion algorithm will be followed for patients exhibiting inadequate hemostasis in the operating room (Flowchart 1). Once patient has a normal TEG result with adequate hemostasis, either heparin or bivalirudin will be used as the anticoagulant. If patients are receiving no anticoagulation or heparin anticoagulation then a second TEG algorithm will be followed in the ICU when hemostasis is normal and heparin is introduced (Flowchart 2). If patients are receiving bivalirudin as their anticoagulation strategy, the transfusion parameters with TEG application will not apply. In addition to determining the compliance and feasibility of following these TEG algorithms, clinical outcome data including transfusion rates, types of blood products transfused, estimated blood loss and thrombotic events will be collected for every enrolled patient until they are discontinued from ECMO. Statistical analysis of the primary, secondary and tertiary endpoints of this study will determine the likelihood of exploring future clinical trials involving TEG-driven coagulation and transfusion management of the ECMO population.
Interventions
DEVICEThromboelastograph
A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
Sponsors
American Heart Association
Stephen Esper
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient's requiring ECMO placement
Exclusion criteria
* Other than children less than 18 years of age, no one will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time | From time patient is placed on ECMO to 30-days post ECMO initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus | From the time patient is placed on ECMO to 30-days post ECMO initiation | Number of patients who experienced bleeding while on ECMO |
| Chest Tube Output and Overall Estimated Blood Loss | From time patient is placed on ECMO to 30-days post ECMO initiation | Average chest tube output |
| Time Between Transfusions | From time patient is placed on ECMO to 30-days post ECMO initiation | — |
| Type of Blood Products Transfused | From time patient is placed on ECMO to 30-days post ECMO initiation | — |
| Pump Exchanges Required | From time patient is placed on ECMO to 30-days post ECMO initiation | Number of participants who required pump exchanges |
| Number of Transfusions Required While on ECMO | From the time patient is placed on ECMO to 30-days post ECMO initiation | Number of patients who required transfusions |
| Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange) | From time patient is placed on ECMO to 30-days post ECMO initiation | Number of participants with pump circuit clotting |
| Time to Weaning From/Removal of ECMO | From time patient is placed on ECMO until time to weaning from ECMO | Average time to ECMO removal |
| Need for Surgical Intervention for Hemorrhage | From time patient is placed on ECMO to 30-days post ECMO initiation | Number of participants |
| Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results | From time patient is placed on ECMO to 30-days post ECMO initiation | — |
| Oxygenator Exchanges | From time patient is placed on ECMO to 30-days post ECMO initiation | NUmber of participants who required oxygenator exchanges while on ECMO |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Pilot Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 47.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time | 4 Participants |
Secondary
Chest Tube Output and Overall Estimated Blood Loss
Average chest tube output
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pilot Arm | Chest Tube Output and Overall Estimated Blood Loss | 2692 ML |
Secondary
Need for Surgical Intervention for Hemorrhage
Number of participants
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Need for Surgical Intervention for Hemorrhage | 9 Participants |
Secondary
Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus
Number of patients who experienced bleeding while on ECMO
Time frame: From the time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus | 11 Participants |
Secondary
Number of Transfusions Required While on ECMO
Number of patients who required transfusions
Time frame: From the time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Number of Transfusions Required While on ECMO | 9 Participants |
Secondary
Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange)
Number of participants with pump circuit clotting
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Occurrence of Pump Circuit Clotting and Clots in the Oxygenator (Visible Clot Which Did Not Require Circuit/Pump Exchange) | 2 Participants |
Secondary
Oxygenator Exchanges
NUmber of participants who required oxygenator exchanges while on ECMO
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
Population: Data not analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Oxygenator Exchanges | 3 Participants |
Secondary
Pump Exchanges Required
Number of participants who required pump exchanges
Time frame: From time patient is placed on ECMO to 30-days post ECMO initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pilot Arm | Pump Exchanges Required | 4 Participants |
Secondary
Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results
Time frame: 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.
Secondary
Time Between Transfusions
Time frame: 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
Secondary
Time to Weaning From/Removal of ECMO
Average time to ECMO removal
Time frame: From time patient is placed on ECMO until time to weaning from ECMO
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pilot Arm | Time to Weaning From/Removal of ECMO | 19315 minutes |
Secondary
Type of Blood Products Transfused
Time frame: 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.