Use of ROTEM for Multi-level Spine Surgery

A Prospective Observational Study to Evaluate Perioperative Coagulation Profiles Using Rotational Thromboelastometry (ROTEM®) in Patients Undergoing Multi-level Spine Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00839995

Acronym

ROTEM

Enrollment

Registered

2009-02-10

Start date

2009-02-28

Completion date

2011-12-31

Last updated

2012-03-05

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

Conditions

Coagulation

Keywords

To determine the efficacy of ROTEM on assessing coagulation profiles.

Brief summary

The purpose of this study is to obtain coagulation profiles of patients undergoing multi-level spine surgeries with ROTEM® and routine coagulation tests. The investigators will compare the data from ROTEM® and routine coagulation tests with each other and with blood loss and transfusion therapies used.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients undergoing elective open spine (cervical, thoracic, and/or lumbar) surgery with anticipated blood loss of \> 1 L * Males and females * Age 18 to 100 years of age * ASA physical status 1 to 3 * Arterial line indicated for the intraoperative management of the patient and in place prior to incision * Informed consent obtained

Exclusion criteria

* Known pre-existing hemostatic abnormality * Known clopidogrel use within 10 days prior to surgery * Known warfarin use within 5 days prior to surgery * Known pregnancy * Has physical, mental, or medical conditions which, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation. * Inclusion in another clinical research study * An investigator of this study * Subject's refusal or inability to agree to and sign the Informed Consent form in English

Design outcomes

Primary

Measure	Time frame
Coagulation profiles.	One measurement before surgery, one after surgery is completed, and one measurement at each i-stat or 10% total blood volume loss.

Countries

United States

Outcome results