Comparison of Rapid Thrombelastography and Conventional Coagulation Testing for Haemostatic Resuscitation in Trauma

NCT01536496 | Completed Results

• 1 other identifier: COMIRB # 10-0477
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coagulopathy

Keywords

trauma; hemorrhagic shock; thrombelastography; coagulopathy; transfusion; resuscitation

Outcome Measures

Primary Outcomes (1)

• 28 Day In-hospital Mortality

  28 days in hospital

Secondary Outcomes (14)

• Deaths Specified as Early Mortality (<6 Hours Post-injury) and Delayed Mortality (6-24 Hours Post-injury).

  Within 24 hours post-injury.

• Deaths Related to Coagulopathic Bleeding Based Upon Clinical Impressions of the Treating Surgeons and Review of Operative Records and Outcome (Hours Since Injury).

  Up to 28 days post-injury.

• Time to Death From Injury in Hours.

  From time of injury to 28th day of hospitalization.

• Change in INR Test Results.

  Within first 6 hours post-injury, 12 and 24 hours post-injury.

• Change in Fibrinogen Test Results.

  Within first 6 hours post-injury, 12 and 24 hours post-injury.

Study Arms (2)

Control (INR, PTT, fibrinogen, D-dimer)

ACTIVE COMPARATOR

Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Biological: Blood product transfusion based on conventional coagulation tests.

Test (r-TEG)

ACTIVE COMPARATOR

Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.

Biological: Blood product transfusion based on rapid thrombelastography (r-TEG) results.

Interventions

Blood product transfusion based on conventional coagulation tests. BIOLOGICAL

Transfusion of blood products.

Control (INR, PTT, fibrinogen, D-dimer)

Blood product transfusion based on rapid thrombelastography (r-TEG) results. BIOLOGICAL

Transfusion of blood products.

Test (r-TEG)

Eligibility Criteria

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

You may qualify if:

• Male or female, age \>18 years admitted to Denver Health Medical Center.
• Blunt or penetrating trauma sustained \< 6 hours before admission, with Injury Severity Score \> 15 (ISS\>15), likely to require transfusion of RBC within 6 hours from admission as indicated by clinical assessment.

You may not qualify if:

• Age \< 18 years.
• Known inherited defects of coagulation function (e.g. hemophilia, Von Willebrand's disease).
• Prisoner.
• Pregnancy.

Sponsors & Collaborators

• Denver Health and Hospital Authority: lead
• Haemonetics Corporation: collaborator

Study Sites (1)

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Shock, Hemorrhagic; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Ernest E. Moore
• Organization: Denver Health Medical Center

Ernest.Moore@dhha.org

303.602.1817

Study Officials

• Ernest E. Moore, M.D.

  Denver Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgery/Trauma Service

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: February 22, 2012
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 8, 2019
• Results First Posted: February 17, 2016

Record last verified: 2018-12

Locations

US (1)