N/A
N=112
Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery
Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT02740374 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion — 24; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ROTEM (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Needing an Intraoperative Autologue Blood Product Transfusion |
24; 24 | — |
| SECONDARY Postoperative Blood Product Transfusion |
1; 3 | — |
| SECONDARY Number of Participants Requiring Cryoprecipitate Transfusion |
1; 2 | — |
| SECONDARY Number of Participants Requiring Platelet Transfusion |
1; 6 | — |
| SECONDARY Fibrinogen Concentrate Transfusion Requirements |
0; 0 | — |
| SECONDARY Prothrombin Complex Transfusion Requirements |
0; 0 | — |
| SECONDARY Factor VII Transfusion Requirements |
0; 0 | — |
| SECONDARY Need for Mechanical Ventilation During Postoperative Period |
8; 3 | — |
| SECONDARY Length of Stay on Intensive Care Unit (ICU) |
3952.38; 4915.85 | — |
| SECONDARY Length of Stay on Post Anesthesia Care Unit (PACU) |
183.03; 171.81 | — |
| SECONDARY Overall Hospital Stay |
8535.49; 1095.61 | — |
| SECONDARY Surgical Site Infection |
3; 6 | — |
| SECONDARY Mortality |
1; 1 | — |
| SECONDARY Cardiovascular Complications Rate |
2; 0 | — |
| SECONDARY Thromboembolic Complications Rate |
0; 2 | — |
| SECONDARY Respiratory Complications Rate |
3; 4 | — |
| SECONDARY Renal System Complications Rate |
1; 2 | — |
| SECONDARY Cerebrovascular Complications Rate |
0; 1 | — |
| SECONDARY Infectious Complications Rate |
1; 5 | — |
| SECONDARY Reintervention Related to Postoperative Bleeding Rate |
5; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
-
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02740374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.