Trial Outcomes & Findings for Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients (NCT NCT02388776)

Last Updated: 2018-07-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

21 days

Results posted on

2018-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	ROTEM Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels. 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.
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ROTEM Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels. 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.
Overall Study Death	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ROTEM n=2 Participants Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels. 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.
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants
Sex: Female, Male Female	1 Participants n=2 Participants
Sex: Female, Male Male	1 Participants n=2 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Data not collected for two subjects for all time points for primary outcome due to subject being discharged from hospital and subject death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 21 days

Population: Only two subjects enrolled, one withdrawn early due to death and the second lost to follow up prior to the completion of the final ROTEM testing.

To assess whether ROTEM abnormalities correlate with allogenic blood product administration by blinded ICU physicians

Outcome measures

Outcome data not reported

Adverse Events

Active Arm

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Active Arm n=2 participants at risk Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels. 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure; grade 4	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Respiratory, thoracic and mediastinal disorders Contusion/pneumonia; grade 3	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Immune system disorders SIRS; grade 3	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Renal and urinary disorders Anuria; grade 4	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Metabolism and nutrition disorders Metabolic acidosis; grade 4	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Metabolism and nutrition disorders Hemachromaturia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Renal and urinary disorders Acute renal failure	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Skin and subcutaneous tissue disorders Massive anasarca	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Thrombocytopenia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.

Other adverse events

Other adverse events
Measure	Active Arm n=2 participants at risk Clinical burn ICU Inpatients receiving blood draws for ROTEM analysis and fibrinogen levels. 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.
Metabolism and nutrition disorders Protein calorie malnutrition	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Abnormal lab value/low hemoglobin	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Abnormal lab value/low hematocrit	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Abnormal lab value/high INR	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Metabolism and nutrition disorders Hyperglycemia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Infections and infestations Cellulitis	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Metabolism and nutrition disorders Hypermetabolism	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Abnormal lab value/hemoglobin dropped from 8.2 to 7	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
General disorders Fever	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Hypoalbuminemia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Infections and infestations MSSA and Klebsiella	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Blood and lymphatic system disorders Abnormal lab value/high sodium and uptrending creatinine	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Eye disorders Thermal keratopathy, right eye	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Eye disorders Bilateral upper and lower eyelid swelling	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Cardiac disorders Cardiac ischemia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Gastrointestinal disorders Red blood per rectum	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Respiratory, thoracic and mediastinal disorders Pleural fluid	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
General disorders Hypothermia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.
Immune system disorders Leukopenia	50.0% 1/2 • Adverse event data was collected over a five month period. Serious adverse events were defined as Grade 3-5 events, as defined by the NIH. All other adverse events were events defined as Grade 1-2.

Additional Information

Christine Lennon, M.D.

Weill Cornell Medicine

Phone: 212-746-2621

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place