Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients

NCT02388776 | Terminated Results

• 1 other identifier: 1404014977
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional pilot study of 40 burn inpatients. Specific aims of the proposed pilot study are to use bedside blood analysis with rotational thromboelastometry (ROTEM) in severe burn patients to provide preliminary information on the nature of coagulation abnormalities and compare subject ROTEM coagulation profiles within 24 hours of burn injury (day 1) and on days 2, 3, 5, 7, 14 and 21 after burn injury.

Conditions

Burn

Keywords

ROTEM; Fibrinogen

Outcome Measures

Primary Outcomes (1)

• Coagulation Parameters

  To compare ROTEM coagulation parameters involving fibrin contribution to clot formation (FIBTEM) between patients on admission/enrollment (day 1), and on days 2, 3, 5, 7, 14 and 21 after burn injury to see if expected hypercoagulability shows evidence of resolution.

  21 days

Secondary Outcomes (1)

• Predictive Value of ROTEM Data

  21 days

Study Arms (1)

ROTEM

EXPERIMENTAL

Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels.

Device: ROTEM

Interventions

ROTEM DEVICE

A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.

Also known as: ROTEM delta

ROTEM

Eligibility Criteria

• Age: 3 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients admitted to NYPH with 15% TBSA burn or greater.
• Patients with vascular access catheters (arterial or central line) placed within 24 hours of burn injury
• Males and females
• Ages \>3 years or \>15 kg
• Informed verbal consent obtained from the patient or the patient's designated health care proxy (DHCP). In the case of minors, assent and informed verbal consent obtained from at least one parent or guardian.

You may not qualify if:

• Known pre-existing hemostatic abnormalities
• Ages \< 3 years or weight \< 15 kg
• Intake of anticoagulants or antiplatelet aggregation inhibitors prior to burn
• Pregnant patients
• Patients with delayed presentation (greater than 24 hours after burn injury)
• Refusal or inability of patient or patient's DHCP to consent in English.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. Small numbers of subjects due to the critical condition of subject population.

Results Point of Contact

• Title: Christine Lennon, M.D.
• Organization: Weill Cornell Medicine

chl9083@med.cornell.edu

212-746-2621

Study Officials

• Christine Lennon, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: March 17, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 5, 2018
• Results First Posted: April 19, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)