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

Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients: A Prospective Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Burn
• Intervention / Treatment: Device: ROTEM

Detailed Description

Specific aims of this pilot study are to use bedside blood analysis with ROTEM in severe burn patients to provide preliminary information on the nature of coagulation abnormalities and to 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. Investigators hypothesize that ROTEM analysis will detect a pattern of impaired coagulation in severely burned patients.

ROTEM analysis:

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. Blood will be obtained for ROTEM/ fibrinogen levels from each subject seven times during their hospital admission: once within 24 hours of burn injury (day 1), and on days 2, 3, 5, 7, 14 and 21. For each sample, 5.4 mL of whole blood will be collected into 2 citrated tubes (2.7 mL in each tube). For all subjects, both pediatric and adult, blood will be collected via an indwelling catheter (arterial or central line). One 2.7 ml tube will be used for ROTEM analysis. The amount of blood is in accordance with the acceptable limit of ROTEM analysis. ROTEM testing will be performed according to the manufacturer's instructions using test kit reagents. Members of the clinical research team who have been trained and certified to use the ROTEM device will perform the appropriate ROTEM tests. The second 2.7 mL citrated tube will be used to measure fibrinogen level, using the automated central laboratory device in hospital.

In this interventional study, the ROTEM data will be blinded to the treating Burn ICU physicians and will have no effect on standard perioperative and ICU treatment. The ROTEM machine will be located in a designated spot outside of the ICU, out of view of the treating clinicians. Thus, volume replacement, thrombosis prophylaxis, and other management (including blood product transfusions) will be performed according to existing protocols.

Demographic information will be de-identified, but will include demographics (age, sex) and each subject's medical and surgical history, burn injury type (thermal, chemical, electrical, inhalational, plus/minus additional injury - i.e. Trauma/TBI, etc) and percent Total Body Surface Area (TBSA) as diagrammed by the Burn ICU on admission, medications (specifically, form of venous thromboembolism prophylaxis as prescribed by ICU physicians during the study period), weight, vital signs, dates of surgical intervention (bedside escharotomies and OR procedures), dates and types of blood product administration, fluid balance per day, number of days intubated, number of ICU days, hospital LOS, mortality, and ISS. Laboratory values: (on days 1, 2, 3, 5, 7, 14, and 21) will include fibrinogen, PT, INR, aPTT, and CBC when available as standard of care.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Consecutive patients admitted to NYPH with 15% TBSA burn or greater.
2. Patients with vascular access catheters (arterial or central line) placed within 24 hours of burn injury
3. Males and females
4. Ages >3 years or >15 kg
5. 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.

Exclusion Criteria:

1. Known pre-existing hemostatic abnormalities
2. Ages < 3 years or weight < 15 kg
3. Intake of anticoagulants or antiplatelet aggregation inhibitors prior to burn
4. Pregnant patients
5. Patients with delayed presentation (greater than 24 hours after burn injury)
6. Inclusion in another clinical research study
7. Refusal or inability of patient or patient's DHCP to consent in English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: ROTEM; 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.; Other Names: ROTEM delta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive Value of ROTEM Data	To assess whether ROTEM abnormalities correlate with allogenic blood product administration by blinded ICU physicians	21 days

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Christine Lennon, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: February 2, 2015
• First Submitted That Met QC Criteria: March 9, 2015
• First Posted (Estimate): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): July 5, 2018
• Last Update Submitted That Met QC Criteria: June 5, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: ROTEM; Fibrinogen
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 1404014977

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share IPD