Cirrhosis, Coagulopathy
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DEVICEROTEM
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.
OTHERConventional Therapy
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.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 and older, admitted to the hospital * Patients who have clinically documented cirrhosis * Patients who are coagulopathic (INR \> 1.5 and/or platelets \< 50,000) * Patients undergoing an endoscopic procedure or neurosurgical procedure
Exclusion criteria
* Patients must not be pregnant * Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis) * Patients must not have an active infection (per PI discretion) * Patients must not have any known hemostatic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-operative Blood Loss | Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span). | Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Bleeding Events | 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). | 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). |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 34 |
| 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. | 34 |
| Total | 68 |
Baseline characteristics
| Characteristic | ROTEM | Conventional | Total |
|---|---|---|---|
| Age, Categorical Age <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age Between 18 and 65 years | 34 Participants | 34 Participants | 68 Participants |
| Indication for OLT | 34 Participants | 34 Participants | 68 Participants |
| Model for End-Stage Liver Disease Scale (MELD) score Conventional | — | 22 units on a scale STANDARD_DEVIATION 7.7 | 22 units on a scale STANDARD_DEVIATION 7.7 |
| Model for End-Stage Liver Disease Scale (MELD) score ROTEM | 25 units on a scale STANDARD_DEVIATION 8.37 | — | 25 units on a scale STANDARD_DEVIATION 8.37 |
| Presence of hepatocellular carcinoma | 13 Participants | 10 Participants | 23 Participants |
| Presence of hypercoaguable state | 0 Participants | 2 Participants | 2 Participants |
| Presence of portal vein thrombosis | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity : Non-white | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Race/Ethnicity : White | 31 Participants | 31 Participants | 62 Participants |
| Region of Enrollment United States | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 25 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 | 0 / 34 |
Outcome results
Primary
Intra-operative Blood Loss
Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.
Time frame: Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ROTEM | Intra-operative Blood Loss | 2000 milliliters |
| Conventional | Intra-operative Blood Loss | 3000 milliliters |
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).
Time frame: 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).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ROTEM | Number of Participants With Bleeding Events | 1 participants |
| Conventional | Number of Participants With Bleeding Events | 0 participants |