Incidence of hypercoagulability and thromboembolism in dogs with surgically treated primary hepatocellular and adrenal neoplasia
The goal of this study is to characterize the hemostatic abnormalities in dogs with primary hepatocellular or primary adrenal cancer undergoing surgical removal and to determine when their hypercoagulability (increased tendency for blood to clot) resolves post-operatively. Additionally, we aim to determine the incidence of thromboembolism (blood clots) in hypercoagulable patients diagnosed with primary hepatocellular or primary adrenal cancer following tumor removal.
Dogs with suspected primary hepatocellular or adrenal neoplasia will undergo standard-of-care procedures, including blood work (CBC, chemistry, and PT/PTT) and CT of the abdomen. Upon enrollment, a TEG and fibrinogen level will be obtained before surgery for the study. Dogs will return in 10-14 days for re-check full-body CT and blood work (PCV/TS, TEG, PLT, fibrinogen). Dogs will return in 15-21 days for re-check blood work. Dogs will continue to return for recheck blood work (PCV/TS, TEG, fibrinogen, and PLT) until their hypercoagulability, based on an elevated TEG G-value, resolves.
If a dog remains hypercoagulable at the 10-14 day post-surgery visit, they will be asked to come back for 3 and/or 4-week post-surgery visits until their hypercoagulability resolves. If a dog remains hypercoagulable at the 4-week post-surgery visit, it will present as needed for 6, 8,12, and/or 16-week post-operative visits until their hypercoagulability resolves. If a dog remains hypercoagulable at the 16-week post-operative visit, blood work re-checks will move to a monthly schedule until resolution is achieved. No future visits are required once a dog becomes normocoagulable. No future visits are required, and monthly blood work will discontinue if a dog remains hypercoagulable at 6 months post-operative (day 182).
Client Compensation
The clinical trial will cover the cost of your dog's pre-operative chest and post-operative abdominal and chest computed tomography (CT) scan. Additionally, the study will cover the cost of each recheck examination fee and the cost of performing blood work (TEG, PCV/TS, platelet count, and fibrinogen) pre and post-operatively.
Routine blood work (PT, PTT, CBC, chemistry panel, blood type prior to surgery) will not be covered by the study. The study does not cover the cost of your dog's pre-operative workup (primary tumor biopsy/FNA, pre-operative abdominal CT, thoracic radiographs, etc.), primary tumor removal, hospitalization, post-operative care, or additional oncologic care (radiation therapy or chemotherapy). Costs associated with adverse events (including but not limited to hematoma and incisional complications) are not covered by the study.
Potential Medical Benefits:
All patients enrolled in this study will receive current standard of care treatment. The findings of this study have the potential to inform the knowledge and practice of surgeons.
Potential Medical Risks:
Dogs can develop local irritation or an allergic reaction to the contrast given intravenously for computed tomography. Additionally, dogs could develop a hematoma at the venipuncture site from their blood draw.
What qualifies my pet for enrollment?
Inclusion Criteria:
Eligible patients (any breed of dog) must meet all the following:
- Dogs greater than 5kg in weight
- Dogs with primary hepatic or adrenal cancer
- Dogs hypercoagulable on thromboelastography
Exclusion Criteria:
- Dogs less than 5 kg in weight
- Dogs with a histopathological diagnosis not consistent with primary hepatic or adrenal cancer following tumor removal.
- Dogs with endocrine disease (Cushing's)
- Dogs with an active hemoabdomen (blood in the abdomen)
- Dogs with evidence of hepatic failure
- Dogs with evidence of renal disease (azotemia)
- Dogs with anemia or thrombocytopenia
- Dogs currently on anti-coagulant therapy
- Dogs not hypercoagulable on thromboelastography
Diagnosis/Condition Being Studied:
Primary hepatocellular or primary adrenal cancer
Intervention Name:
Incidence of thromboembolism
Primary Outcome:
Thromboelastography (TEG) will be performed to measure hemostatic variables associated with
coagulation. Additionally, we will measure the following hemostatic variables: packed cell volume, total solids,
fibrinogen, and platelet count. In addition to hemostatic variables, we will be performing computed tomography (CT),
to record the incidence of thromboembolism.
Primary Outcome Measure:
Blood draws will be performed and then blood analyzers will be used to obtain our hemostatic variables. We will determine the incidence of thromboembolism with computed tomography scans of each dog.
Primary Outcome Endpoint:
To determine the mean day post-operative hypercoagulability resolves. To determine the incidence of thromboembolism in this population of hypercoagulable dogs.
PRE-SCREENING QUESTIONAIRE
If you believe your pet may be eligible for this study, please complete a pre-screening questionnaire.