Use of ROTEM for Multi-level Spine Surgery | NCT00839995

Studies
Use of ROTEM for Multi-level Spine Surgery

NCT00839995

Sponsor

Weill Medical College of Cornell University

Status

Completed

Last Update Posted

Mar 5, 2012Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

Coagulation

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Feb 6, 2009

First Submission Date that Met QC Criteria

Feb 9, 2009

First Posted Date

Feb 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2012

Last Update Posted Date

Mar 5, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hugh Hemmings, Vice Chair of Research, Weill Medical College of Cornell UniversityPrincipal Investigator

Lead Sponsor

Weill Medical College of Cornell UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

41Actual

Label	Type	Description	Intervention Names
Patients undergoing multi-level spine surgery

Outcomes Module

Primary Outcomes

Measure	Description	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Large metropolitan hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugh C Hemmings, M.D., Ph.D.	Weill Medical College of Cornell University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17538089	Background	Mannucci PM, Levi M. Prevention and treatment of major blood loss. N Engl J Med. 2007 May 31;356(22):2301-11. doi: 10.1056/NEJMra067742. No abstract available.
17380100	Background	Kozek-Langenecker S. Management of massive operative blood loss. Minerva Anestesiol. 2007 Jul-Aug;73(7-8):401-15. Epub 2007 Mar 27.

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases