Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery

NCT02740374 | Completed Results

• 1 other identifier: 2014H0447
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood Products vs control cases without ROTEM assessment.

Conditions

Blood Loss, Surgical

Keywords

ROTEM; Thromboelastometry; spine surgery; allogenic blood transfusion; blood loss; red blood cell transfusion

Outcome Measures

Primary Outcomes (1)

• Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion

  Intraoperative Autologue Blood Product Transfusion

  Within surgery

Secondary Outcomes (19)

• Postoperative Blood Product Transfusion

  Within postoperative 24 hours

• Number of Participants Requiring Cryoprecipitate Transfusion

  Perioperative- up to 24 hours after surgery start time (cumulative)

• Number of Participants Requiring Platelet Transfusion

  Perioperative- up to 24 hours after surgery start time (cumulative)

• Fibrinogen Concentrate Transfusion Requirements

  Within Surgery and Postoperative 24 hours

• Prothrombin Complex Transfusion Requirements

  Within Surgery and Postoperative 24 hours

Other Outcomes (1)

• Cost Comparison

  within 30 days after surgery

Study Arms (2)

ROTEM

EXPERIMENTAL

ROTEM will be performed in patients with signs of clinically relevant bleeding and in whom blood transfusion is considered (Temp above 35 Celsius degrees; pH below 7.2; Cai above 4.6 mg/dL; Hb below 9g/dL, or below 10g/dL with anticipated greater blood loss) or at a fixed range every 2 hours or at Anesthesiologist criteria based on patient's clinical situation. There will be also be performed standard of care test for this set of patients, as described for the CONTROL arm. ROTEM results will guide transfusion strategy.

Device: ROTEM

CONTROL/STANDARD OF CARE

ACTIVE COMPARATOR

If patients are randomized to standard coagulation tests (SCT), these will be performed according to Ohio State Wexner University Medical Center standard practices and attending's criteria, or at 2 hour intervals per protocol. Standard of care tests include but are not limited to: hemoglobin, platelet count, fibrinogen concentration, INR, aPTT, and PT. These will be performed at fixed time points (preoperatively, every 2 hours intraoperatively, procedure completion, and 24 hours after procedure completion). Arterial blood gases will be performed repetitively intraoperatively at a fixed range every 1-hour or at attending's criteria, as well as any postoperative laboratory tests. SCT will guide transfusion management.

Other: Standard of Care

Interventions

ROTEM DEVICE

ROTEM coagulation assessment and guided transfusion management.

ROTEM

Standard of Care OTHER

Standard Coagulation Tests assessment and guided transfusion management

CONTROL/STANDARD OF CARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 years or older.
• Able to provide inform consent or have a legal authorized representative able to sign consent on the patients behalf.
• Female subject with a negative urine or serum pregnancy test, or not of childbearing potential, defined as surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy; or are postmenopausal for at least 1 year.
• Patients schedule to undergo elective neurosurgery, orthopedic, or combined procedures that are expected to receive blood products intraoperatively.

You may not qualify if:

• Subjects younger than 18 years old.
• Subjects who are prisoners.
• Subjects who refuse transfusion of blood products.
• Females who are pregnant or breastfeeding.
• Subjects unable to participate in the study for any reason in the opinion of the Principal Investigator.

Sponsors & Collaborators

• Ohio State University: lead

MeSH Terms

Conditions

Blood Loss, Surgical; Hemorrhage

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Alberto Uribe
• Organization: The Ohio State University Wexner Medical Center - Department of Anesthesiology

alberto.uribe@osumc.edu

6142933559

Study Officials

• Galina Dimitrova, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Principal INvestigator, Clinical Associate Professor

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: April 15, 2016
• Study Start: November 1, 2015
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: November 4, 2022
• Results First Posted: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share