N/A
N=114
Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma
Acute Coagulopathy
Bottom Line
View on ClinicalTrials.gov: NCT01536496 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: 28 Day In-hospital Mortality — 20; 11 participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood product transfusion based on conventional coagulation tests. (Biological); Blood product transfusion based on rapid thrombelastography (r-TEG) results. (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 28 Day In-hospital Mortality |
20; 11 | 0.04 sig |
| SECONDARY Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury). |
12; 4; 8; 7 | — |
| SECONDARY Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury). |
11; 5 | — |
| SECONDARY Time to Death From Injury in Hours. |
4.2; 10.4 | — |
| SECONDARY Change in INR Test Results. |
1.5; 1.8; 1.4; 1.4; 1.5; 1.4 | — |
| SECONDARY Change in Fibrinogen Test Results. |
161.5; 153; 185.5; 159; 233; 203 | — |
| SECONDARY Change in Platelet Count Test Results. |
90; 100; 116; 110; 96.5; 109 | — |
| SECONDARY Change in D-dimer Test Results. |
8.3; 8.7; 8; 6.4; 5.4; 5 | — |
| SECONDARY Change in r-TEG ACT (Activated Clotting Time) Test Results. |
124; 121; 128; 121; 128; 128 | — |
| SECONDARY Change in r-TEG Angle Test Results. |
70.8; 68.2; 68.5; 65.5; 69.1; 71.3 | — |
| SECONDARY Change in r-TEG Maximal Amplitude (MA) Test Results. |
53.8; 51; 55; 56.9; 56.5; 56.9 | — |
| SECONDARY Change in r-TEG LY30 Test Results. |
0; 0; 0.3; 0.1; 0.7; 0.7 | — |
| SECONDARY Composition and Quantity of Blood Products Transfused at 24 Hours Post-injury |
11.0; 9.5; 6.0; 5; 1.0; 0 | — |
| SECONDARY Length of Stay (Days) in the Surgical Intensive Care Unit (SICU) Reported as ICU-free Days and Number of Days on the Ventialator Reported as Ventilator Free Days. |
8.5; 16; 13; 18 | — |
| SECONDARY Number of Participants With Multiple Organ Failure (MOF) During This Hospitalization. |
3; 2 | — |
Summary
The purpose of this study is to compare rapid thrombelastography (r-TEG) with conventional coagulation testing for diagnosing and treating coagulation abnormalities in severely injured patients who are likely to require transfusion therapy.
Eligibility Criteria
Inclusion Criteria
- Male or female, age >18 years admitted to Denver Health Medical Center.
- Blunt or penetrating trauma sustained 15 (ISS>15), likely to require transfusion of RBC within 6 hours from admission as indicated by clinical assessment.
Exclusion Criteria
- Age 2.0 mg/dL). Advanced cirrhosis discovered on laparotomy will be a criterion for study withdrawal and exclusion of conventional coagulation or r-TEG/TEG data from the analysis).
- Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease).
- Prisoner.
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT01536496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.