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A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).
Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROTEM | Experimental | Transfusion guided by ROTEM during OLT |
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| Conventional | Active Comparator | Transfusion guided by conventional labs |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROTEM | Device | Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group. |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-operative Blood Loss | Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures. | Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bleeding Events | Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months). | Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam J Hanje, MD | Assistant Professor-Clinical | Principal Investigator |
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This is a prospective, single center, randomized clinical trial. 34 controls had transfusions guided by conventional labs and 34 participants had transfusions guided by ROTEM during orthotopic liver transplantation.
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| ID | Title | Description |
|---|---|---|
| FG000 | ROTEM | Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group. |
| FG001 | Conventional |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2020 | Mar 10, 2020 |
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| Conventional Therapy | Other | Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group. |
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Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ROTEM | Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets & 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin. |
| BG001 | Conventional | Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at < 100 mg/dL, 1 unit of cryoprecipitate was also transfused. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Classified as "white/non-white." | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Indication for OLT | Count of Participants | Participants |
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| Model for End-Stage Liver Disease Scale (MELD) score | MELD score is a scale from 6-40, with a higher score indicating a worse outcome. | Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm. | Mean | Standard Deviation | units on a scale |
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| Presence of hepatocellular carcinoma | Count of Participants | Participants |
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| Presence of portal vein thrombosis | Count of Participants | Participants |
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| Presence of hypercoaguable state | Count of Participants | Participants |
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| 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 | Intra-operative Blood Loss | Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures. | Posted | Median | Inter-Quartile Range | milliliters | Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span). |
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| Secondary | Number of Participants With Bleeding Events | Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months). | Posted | Number | participants | Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months). |
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1 year
Standard definition from clinicaltrials.gov
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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 | ROTEM | Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG001 | Conventional | Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group. | 0 | 34 | 0 | 34 | 0 | 34 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A James Hanje | The Ohio State University | 614 293 6255 | james.hanje@osumc.edu |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 9, 2017 | Mar 10, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Race/Ethnicity : Non-white |
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| Conventional |
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