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A new standard of care was introduced making it impossible to continue with the study. Additionally, some of the blood product and transfusion related outcomes were not collected because this data was not present in the EMR.
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Arm | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thromboelastograph | Device | A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Transfusions Required While on ECMO | Number of patients who required transfusions | From the time patient is placed on ECMO to 30-days post ECMO initiation |
| Number of Participants That Experience Bleeding or Thrombotic-related Adverse Events, Including Deep Venous Thrombosis or Pulmonary Embolus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Esper, MD, MBA | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19767408 | Result | Oliver WC. Anticoagulation and coagulation management for ECMO. Semin Cardiothorac Vasc Anesth. 2009 Sep;13(3):154-75. doi: 10.1177/1089253209347384. | |
| 15507261 | Result | Esmon CT. The impact of the inflammatory response on coagulation. Thromb Res. 2004;114(5-6):321-7. doi: 10.1016/j.thromres.2004.06.028. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Whose Blood Management Care Follows a TEG Algorithm 90% of the Time | Posted | Count of Participants | Participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
|
For the duration of time the participant is on ECMO (24 hours to 6 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Monroe | University of Pittsburgh | 412-623-6382 | monroeal@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2019 | Dec 3, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2019 | Dec 3, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D012140 | Respiratory Tract Diseases |
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|
Number of patients who experienced bleeding while on ECMO |
| From the time patient is placed on ECMO to 30-days post ECMO initiation |
| Chest Tube Output and Overall Estimated Blood Loss | Average chest tube output | From time patient is placed on ECMO to 30-days post ECMO initiation |
| 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 | Number of participants who required pump exchanges | From time patient is placed on ECMO to 30-days post ECMO initiation |
| Oxygenator Exchanges | NUmber of participants who required oxygenator exchanges while on ECMO | From time patient is placed on ECMO to 30-days post ECMO initiation |
| 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 | From time patient is placed on ECMO to 30-days post ECMO initiation |
| Time to Weaning From/Removal of ECMO | Average time to ECMO removal | From time patient is placed on ECMO until time to weaning from ECMO |
| Need for Surgical Intervention for Hemorrhage | Number of participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
| 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 |
| 10564301 | Result | Muntean W. Coagulation and anticoagulation in extracorporeal membrane oxygenation. Artif Organs. 1999 Nov;23(11):979-83. doi: 10.1046/j.1525-1594.1999.06451.x. |
| 12680494 | Result | Colby CE, Sheehan A, Benitz W, Van Meurs K, Halamek LP, Moss RL. Maintaining adequate anticoagulation on extracorporeal membrane oxygenation therapy: Hemochron Junior Low Range versus Hemochron 400. J Extra Corpor Technol. 2003 Mar;35(1):35-8. |
| 8039220 | Result | Reiner JS, Coyne KS, Lundergan CF, Ross AM. Bedside monitoring of heparin therapy: comparison of activated clotting time to activated partial thromboplastin time. Cathet Cardiovasc Diagn. 1994 May;32(1):49-52. doi: 10.1002/ccd.1810320112. |
| 7983877 | Result | Despotis GJ, Summerfield AL, Joist JH, Goodnough LT, Santoro SA, Spitznagel E, Cox JL, Lappas DG. Comparison of activated coagulation time and whole blood heparin measurements with laboratory plasma anti-Xa heparin concentration in patients having cardiac operations. J Thorac Cardiovasc Surg. 1994 Dec;108(6):1076-82. |
| 21412912 | Result | Afshari A, Wikkelso A, Brok J, Moller AM, Wetterslev J. Thrombelastography (TEG) or thromboelastometry (ROTEM) to monitor haemotherapy versus usual care in patients with massive transfusion. Cochrane Database Syst Rev. 2011 Mar 16;(3):CD007871. doi: 10.1002/14651858.CD007871.pub2. |
| 9972747 | Result | Shore-Lesserson L, Manspeizer HE, DePerio M, Francis S, Vela-Cantos F, Ergin MA. Thromboelastography-guided transfusion algorithm reduces transfusions in complex cardiac surgery. Anesth Analg. 1999 Feb;88(2):312-9. doi: 10.1097/00000539-199902000-00016. |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Number of Transfusions Required While on ECMO | Number of patients who required transfusions | Posted | Count of Participants | Participants | From the time patient is placed on ECMO to 30-days post ECMO initiation |
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| 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 | Posted | Count of Participants | Participants | From the time patient is placed on ECMO to 30-days post ECMO initiation |
|
|
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| Secondary | Chest Tube Output and Overall Estimated Blood Loss | Average chest tube output | Posted | Mean | Full Range | ML | From time patient is placed on ECMO to 30-days post ECMO initiation |
|
|
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| Secondary | Time Between Transfusions | 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" | Posted | From time patient is placed on ECMO to 30-days post ECMO initiation |
|
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| Secondary | Type of Blood Products Transfused | 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. | Posted | From time patient is placed on ECMO to 30-days post ECMO initiation |
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| Secondary | Pump Exchanges Required | Number of participants who required pump exchanges | Posted | Count of Participants | Participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
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| Secondary | Oxygenator Exchanges | NUmber of participants who required oxygenator exchanges while on ECMO | Data not analyzed | Posted | Count of Participants | Participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
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| 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 | Posted | Count of Participants | Participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
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| Secondary | Time to Weaning From/Removal of ECMO | Average time to ECMO removal | Posted | Mean | Full Range | minutes | From time patient is placed on ECMO until time to weaning from ECMO |
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| Secondary | Need for Surgical Intervention for Hemorrhage | Number of participants | Posted | Count of Participants | Participants | From time patient is placed on ECMO to 30-days post ECMO initiation |
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| Secondary | Specimen Turn Around Time for Lab Tests (CBC, ACT, PT, PTT, Anti-Xa, INR, Platelet Count) and TEG Results | 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. | Posted | From time patient is placed on ECMO to 30-days post ECMO initiation |
|
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| 3 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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