| Primary | Estimated Blood Loss (mL) | | | Posted | | Mean | Standard Deviation | mL | | during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0002318.8± 1629.3
- OG0013350.0± 1494.6
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | 0.15 | | Mean Difference (Final Values) | 1031.2 | Standard Error of the Mean | 681.7 | 2-Sided | | | | | | | | Other | | |
|
| Primary | Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused | | | Posted | | Mean | Standard Deviation | units of PRBCs | | up to 48 hours after surgery | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Length of Hospital Stay After Surgery | | | Posted | | Mean | Standard Deviation | days | | typically 5-7 days | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Cost Analysis, as Measured by Total Dollar Value of Blood Products Used | | | Posted | | Mean | Standard Deviation | US dollars | | during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Amount of Recovered Blood Transfused During the Procedure (mL) | | | Posted | | Mean | Standard Deviation | mL | | during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Drain Output (mL) | | | Posted | | Mean | Standard Deviation | mL | | first 24 hours after surgery | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Amount of Blood Products Transfused, Measured in Units | | | Posted | | Mean | Standard Deviation | units of blood product | | during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Amount of Blood Products Transfused, Measured in Units | | | Posted | | Mean | Standard Deviation | units of blood product | | 48 hours following surgery | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in Hemoglobin (g/dL) | Reporting the change in hemoglobin from baseline to approximately 10 hours. | | Posted | | Mean | Standard Deviation | g/dL | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in Platelet Count | Reporting the change in platelet count from baseline to approximately 10 hours. | | Posted | | Mean | Standard Deviation | platelets/uL | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in Prothrombin Time | | | Posted | | | | | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in International Normalized Ratio (PT/INR) | | | Posted | | | | | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in Activated Partial Thromboplastin Time (aPTT) | | | Posted | | | | | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |
| Secondary | Change in Fibrinogen (g/L) | | | Posted | | | | | | Baseline and approximately every 2 hours during surgery (up to approximately 10 hours) | | | | ID | Title | Description |
|---|
| OG000 | Rotational Thrombo-elastometry (ROTEM) Group | Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery | | OG001 | Control Group | Patients who are randomized not to receive ROTEM Spine surgery |
| |