Spine SurgeryNCT02758184
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery
A study testing ROTEM-based coagulation monitoring and Spine surgery in people with Spine Surgery and Rotational Thrombo-elastometry (ROTEM), run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spine Surgery, Rotational Thrombo-elastometry (ROTEM)
- What is being tested?
- ROTEM-based coagulation monitoring and Spine surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 16 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 80 years old.
- Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
- Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
- Preoperative hemoglobin Level >10 g/dl.
- OR time > 4 hours.
- No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).
Who cannot join
- Age < 18 or age > 80 years old.
- Anterior spine surgeries or posterior spine surgeries involving <5 levels.
- Minimally invasive spine surgeries.
- Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
- Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values.
- Trauma and Emergency spine surgeries.
Show all 10Show fewer
- Patients with spine malignancy diagnosis, either primary or metastatic.
- OR time < 4 hours.
- Patients who refuse to use allogenic blood products.
- Patients with contraindications for the use of anti-fibrinolytic therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study
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.
Read the 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.
- Being tested
- ROTEM-based coagulation monitoring, Spine surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM-based coagulation monitoringDevice
Spine surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ROTEM Group | Experimental | Patients who are randomized to receive ROTEM Receives: Device: ROTEM-based coagulation monitoring; Procedure: Spine surgery |
| Control Group | Other | Patients who are randomized not to receive ROTEM Receives: Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Blood Loss (mL)
Measured: during surgery (up to approximately 10 hours)
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
Measured: up to 48 hours after surgery
Secondary outcomes (12)
Length of Hospital Stay After Surgery
Measured: typically 5-7 days
Cost Analysis, as Measured by Total Dollar Value of Blood Products Used
Measured: during surgery (up to approximately 10 hours)
Amount of Recovered Blood Transfused During the Procedure (mL)
Measured: during surgery (up to approximately 10 hours)
Drain Output (mL)
Measured: first 24 hours after surgery
Amount of Blood Products Transfused, Measured in Units
Measured: during surgery (up to approximately 10 hours)
Amount of Blood Products Transfused, Measured in Units
Measured: 48 hours following surgery
Change in Hemoglobin (g/dL)
Reporting the change in hemoglobin from baseline to approximately 10 hours.
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Platelet Count
Reporting the change in platelet count from baseline to approximately 10 hours.
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Prothrombin Time
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in International Normalized Ratio (PT/INR)
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Activated Partial Thromboplastin Time (aPTT)
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Fibrinogen (g/L)
Measured: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJun 2016
- Primary completion16 May 2018
- Study completion16 May 2018
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Mendoza-Lattes, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758184
- Sponsor's protocol ID
- Pro00070817
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2016
- Last updated
- 27 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02758184
- Acronym / sponsor ID
- Pro00070817
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 27 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROTEM Group | Experimental | Device: ROTEM-based coagulation monitoring, Procedure: Spine surgeryPatients who are randomized to receive ROTEM |
| Control Group | Other | Procedure: Spine surgeryPatients who are randomized not to receive ROTEM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 and < 80 years old.
- Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
- Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
- Preoperative hemoglobin Level >10 g/dl.
- OR time > 4 hours.
Key exclusion criteria (10 listed)
- Age < 18 or age > 80 years old.
- Anterior spine surgeries or posterior spine surgeries involving <5 levels.
- Minimally invasive spine surgeries.
- Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
- Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEM-based coagulation monitoring | Device | ROTEM Group |
| Spine surgery | Procedure or surgery | Control Group, ROTEM Group |
Primary outcome
Estimated Blood Loss (mL)
Time frame: during surgery (up to approximately 10 hours)
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
Time frame: up to 48 hours after surgery
12 secondary outcomes
Length of Hospital Stay After Surgery
Time frame: typically 5-7 days
Cost Analysis, as Measured by Total Dollar Value of Blood Products Used
Time frame: during surgery (up to approximately 10 hours)
Amount of Recovered Blood Transfused During the Procedure (mL)
Time frame: during surgery (up to approximately 10 hours)
Drain Output (mL)
Time frame: first 24 hours after surgery
Amount of Blood Products Transfused, Measured in Units
Time frame: during surgery (up to approximately 10 hours)
Amount of Blood Products Transfused, Measured in Units
Time frame: 48 hours following surgery
Change in Hemoglobin (g/dL)
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Platelet Count
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Prothrombin Time
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in International Normalized Ratio (PT/INR)
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Change in Fibrinogen (g/L)
Time frame: Baseline and approximately every 2 hours during surgery (up to approximately 10 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Mendoza-Lattes principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROTEM-based coagulation monitoring and Spine surgery in people with Spine Surgery and Rotational Thrombo-elastometry (ROTEM), run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated Blood Loss (mL) (time frame: during surgery (up to approximately 10 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.