Clinical trial NCT02758184: Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery
Official title: Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spine Surgery
Rotational Thrombo-elastometry (ROTEM)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Estimated Blood Loss (mL)
timeFrame: during surgery (up to approximately 10 hours)
measure: Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
timeFrame: up to 48 hours after surgery
Secondary outcomes:
measure: Length of Hospital Stay After Surgery
timeFrame: typically 5-7 days
measure: Cost Analysis, as Measured by Total Dollar Value of Blood Products Used
timeFrame: during surgery (up to approximately 10 hours)
measure: Amount of Recovered Blood Transfused During the Procedure (mL)
timeFrame: during surgery (up to approximately 10 hours)
measure: Drain Output (mL)
timeFrame: first 24 hours after surgery
measure: Amount of Blood Products Transfused, Measured in Units
timeFrame: during surgery (up to approximately 10 hours)
measure: Amount of Blood Products Transfused, Measured in Units
timeFrame: 48 hours following surgery
measure: Change in Hemoglobin (g/dL)
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
measure: Change in Platelet Count
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
measure: Change in Prothrombin Time
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
measure: Change in International Normalized Ratio (PT/INR)
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
measure: Change in Activated Partial Thromboplastin Time (aPTT)
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
measure: Change in Fibrinogen (g/L)
timeFrame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Sergio Mendoza-Lattes
role: PRINCIPAL_INVESTIGATOR
References: