Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery

Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02758184

Enrollment

Registered

2016-05-02

Start date

2016-06-30

Completion date

2018-05-16

Last updated

2022-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotational Thrombo-elastometry (ROTEM), Spine Surgery

Brief summary

The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.

Detailed description

The aim of the study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on reducing total blood product use during complex spine surgery. The primary outcome will include estimated blood losses and blood product utilization during and after surgery (48 hours). Secondary outcomes also include hospital length of stay, and cost analysis of the 2 methodologies.

Interventions

DEVICEROTEM-based coagulation monitoring

PROCEDURESpine surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

1. Age \> 18 and \< 80 years old. 2. Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels. 3. Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation. 4. Preoperative hemoglobin Level \>10 g/dl. 5. OR time \> 4 hours. 6. No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).

Exclusion criteria

1. Age \< 18 or age \> 80 years old. 2. Anterior spine surgeries or posterior spine surgeries involving \<5 levels. 3. Minimally invasive spine surgeries. 4. Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline. 5. Patients with Hemoglobin level of \<10 g/dl on preoperative baseline laboratory values. 6. Trauma and Emergency spine surgeries. 7. Patients with spine malignancy diagnosis, either primary or metastatic. 8. OR time \< 4 hours. 9. Patients who refuse to use allogenic blood products. 10. Patients with contraindications for the use of anti-fibrinolytic therapy.

Design outcomes

Primary

Measure	Time frame
Estimated Blood Loss (mL)	during surgery (up to approximately 10 hours)
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused	up to 48 hours after surgery

Secondary

Measure	Time frame	Description
Amount of Recovered Blood Transfused During the Procedure (mL)	during surgery (up to approximately 10 hours)	—
Drain Output (mL)	first 24 hours after surgery	—
Length of Hospital Stay After Surgery	typically 5-7 days	—
Change in Hemoglobin (g/dL)	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	Reporting the change in hemoglobin from baseline to approximately 10 hours.
Amount of Blood Products Transfused, Measured in Units	during surgery (up to approximately 10 hours)	—
Change in Prothrombin Time	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	—
Change in International Normalized Ratio (PT/INR)	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	—
Change in Activated Partial Thromboplastin Time (aPTT)	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	—
Change in Fibrinogen (g/L)	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	—
Change in Platelet Count	Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)	Reporting the change in platelet count from baseline to approximately 10 hours.
Cost Analysis, as Measured by Total Dollar Value of Blood Products Used	during surgery (up to approximately 10 hours)	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
Rotational Thrombo-elastometry (ROTEM) Group Patients who are randomized to receive ROTEM ROTEM-based coagulation monitoring Spine surgery	11
Control Group Patients who are randomized not to receive ROTEM Spine surgery	10
Total	21

Baseline characteristics

Characteristic	Rotational Thrombo-elastometry (ROTEM) Group	Total	Control Group
Age, Continuous	60.0 years STANDARD_DEVIATION 14	60.6 years STANDARD_DEVIATION 10.9	61.2 years STANDARD_DEVIATION 7.8
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants	19 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	1 Participants	2 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	7 Participants	14 Participants	7 Participants
Region of Enrollment United States	11 Participants	21 Participants	10 Participants
Sex: Female, Male Female	7 Participants	14 Participants	7 Participants
Sex: Female, Male Male	4 Participants	7 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 10
other Total, other adverse events	0 / 11	0 / 10
serious Total, serious adverse events	0 / 11	0 / 10

Outcome results

Primary

Estimated Blood Loss (mL)

Time frame: during surgery (up to approximately 10 hours)

Arm	Measure	Value (MEAN)	Dispersion
Rotational Thrombo-elastometry (ROTEM) Group	Estimated Blood Loss (mL)	2318.8 mL	Standard Deviation 1629.3
Control Group	Estimated Blood Loss (mL)	3350.0 mL	Standard Deviation 1494.6

p-value: 0.15ANOVA

Primary

Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused

Time frame: up to 48 hours after surgery

Arm	Measure	Value (MEAN)	Dispersion
Rotational Thrombo-elastometry (ROTEM) Group	Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused	2.81 units of PRBCs	Standard Deviation 1.99
Control Group	Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused	5.00 units of PRBCs	Standard Deviation 3.59

Secondary

Amount of Blood Products Transfused, Measured in Units

Time frame: 48 hours following surgery

Arm	Measure	Value (MEAN)	Dispersion
Rotational Thrombo-elastometry (ROTEM) Group	Amount of Blood Products Transfused, Measured in Units	0.54 units of blood product	Standard Deviation 0.93
Control Group	Amount of Blood Products Transfused, Measured in Units	1.20 units of blood product	Standard Deviation 1.39

Secondary

Amount of Blood Products Transfused, Measured in Units

Time frame: during surgery (up to approximately 10 hours)

Arm	Measure	Value (MEAN)	Dispersion
Rotational Thrombo-elastometry (ROTEM) Group	Amount of Blood Products Transfused, Measured in Units	4.81 units of blood product	Standard Deviation 4.68
Control Group	Amount of Blood Products Transfused, Measured in Units	7.80 units of blood product	Standard Deviation 8.3

Secondary

Amount of Recovered Blood Transfused During the Procedure (mL)

Time frame: during surgery (up to approximately 10 hours)

Arm	Measure	Value (MEAN)	Dispersion
Rotational Thrombo-elastometry (ROTEM) Group	Amount of Recovered Blood Transfused During the Procedure (mL)	476.3 mL	Standard Deviation 434.3
Control Group	Amount of Recovered Blood Transfused During the Procedure (mL)	879.4 mL	Standard Deviation 755.1

Secondary