Utilization of TEG to Monitor Rivaroxaban Activity

NCT02651909 | Completed

• 1 other identifier: PRO15050224
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patients available as point-of-care testing. Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.

Conditions

Anemia; Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients

  To best observe inhibition of factor Xa, the investigators will perform kaolin TEGs as opposed to alternative forms of activated TEG (rapid-TEG) which may artificially induce coagulation and miss an effect on factor Xa activity. Additional TEG formats that may better target factor Xa inhibition will be investigated in parallel. As a control group, a second cohort of trauma and EGS patients (matched by demographics, injury mechanism, and illness) who are not taking Rivaroxaban will be identified. TEG and coagulation studies will be obtained on admission as described above. Following reversal of Rivaroxaban for subjects that a clinical decision is made to give reversal agents, or at 24 hours post admission for all other subjects, the TEG and PT/PTT/INR will be repeated to assess for changes in both groups.

  2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal

Secondary Outcomes (1)

• TEG as a point-of-care analysis following Rivaroxaban as compared to the standard of care measurement of coagulation.

  2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal

Other Outcomes (1)

• Clinical Outcomes data to be collected from Subject's medical records

  During entire duration of hospital stay, an expected average of 30 days:

Study Arms (2)

Rivaroxaban Cohort

Evidence of Rivaroxaban use with-in the last 48hours Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay

Other: blood sampling

Control cohort not taking Rivaroxaban

Not taking Rivaroxaban - matched to Rivaroxaban group by age gender, type of injury or illness requiring urgent surgery Participating subjects will not undergo any procedures associated with this study except data collection and minimal blood sampling of which results will not be become part of the medical record and no clinical decisions will be made using the results of research lab results. Blood samples are for TEG analysis and for Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay

Other: blood sampling

Interventions

blood sampling OTHER

blood sampling for TEG analysis, Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay

Control cohort not taking Rivaroxaban; Rivaroxaban Cohort

Eligibility Criteria

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

Study Population

Patients that have taken the drug Rivaroxaban with-in the past 48hours that arrive in the ED with traumatic injury or with illness requiring emergent surgery

You may qualify if:

• Age ≥ 18 years
• Evidence of Rivaroxaban use with-in the last 48hours per medical records or report by patient, family, or other healthcare member familiar with patients drug medical history
• Willingness of subject or legally authorized representative to provide written consent for study procedures.

You may not qualify if:

• Known to be pregnant
• Known to be a prisoner
• Known Chronic liver disease
• Documented hypo coagulation condition (hemophilia, Von Willebrands, any congenital factor deficiency (V,X,XII) leukemia)
• Use of any anticoagulant medication other than Rivaroxaban (examples: Warfarin, lovenox, arixtra, fragmin, eliquis)
• Prehospital blood product administration (FFP, platelets, Prothrombin Complex Concentrate (PCC), tranexamic acid (TXA)
• Non-survivable traumatic brain Injury
• Comfort Measure Only (CMO) status

Sponsors & Collaborators

• Matthew Neal MD: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

University of Pittsburgh Medical Center, PUH, 200 Lothrop Street

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Piccini JP, Hellkamp AS, Lokhnygina Y, Patel MR, Harrell FE, Singer DE, Becker RC, Breithardt G, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Relationship between time in therapeutic range and comparative treatment effect of rivaroxaban and warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2014 Apr 22;3(2):e000521. doi: 10.1161/JAHA.113.000521.

  PMID: 24755148 BACKGROUND

• Beyer-Westendorf J, Lutzner J, Donath L, Tittl L, Knoth H, Radke OC, Kuhlisch E, Stange T, Hartmann A, Gunther KP, Weiss N, Werth S. Efficacy and safety of thromboprophylaxis with low-molecular-weight heparin or rivaroxaban in hip and knee replacement surgery: findings from the ORTHO-TEP registry. Thromb Haemost. 2013 Jan;109(1):154-63. doi: 10.1160/TH12-07-0510. Epub 2012 Nov 29.

  PMID: 23197272 BACKGROUND

• Gordon JL, Fabian TC, Lee MD, Dugdale M. Anticoagulant and antiplatelet medications encountered in emergency surgery patients: a review of reversal strategies. J Trauma Acute Care Surg. 2013 Sep;75(3):475-86. doi: 10.1097/TA.0b013e3182a07391. No abstract available.

  PMID: 24089118 BACKGROUND

• Holcomb JB, Minei KM, Scerbo ML, Radwan ZA, Wade CE, Kozar RA, Gill BS, Albarado R, McNutt MK, Khan S, Adams PR, McCarthy JJ, Cotton BA. Admission rapid thrombelastography can replace conventional coagulation tests in the emergency department: experience with 1974 consecutive trauma patients. Ann Surg. 2012 Sep;256(3):476-86. doi: 10.1097/SLA.0b013e3182658180.

  PMID: 22868371 BACKGROUND

• Muller MC, Meijers JC, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Crit Care. 2014 Feb 10;18(1):R30. doi: 10.1186/cc13721.

  PMID: 24512650 BACKGROUND

• Bowry R, Fraser S, Archeval-Lao JM, Parker SA, Cai C, Rahbar MH, Grotta JC. Thrombelastography detects the anticoagulant effect of rivaroxaban in patients with stroke. Stroke. 2014 Mar;45(3):880-3. doi: 10.1161/STROKEAHA.113.004016. Epub 2014 Jan 14.

  PMID: 24425115 BACKGROUND

MeSH Terms

Conditions

Anemia; Venous Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Matthew D Neal, MD

  University of Pittsburgh, Division of Trauma and Acute Care Surgery Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Matthew D. Neal, MD

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: January 11, 2016
• Study Start: April 1, 2016
• Primary Completion: July 7, 2018
• Study Completion: November 4, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Locations

US (1)