Perioperative Bleeding and Aspirin Use in Spine Surgery
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/22/2016 |
| Start Date: | July 2016 |
| End Date: | December 2019 |
| Contact: | Jason Eubanks, MD |
| Email: | Jason.Eubanks@uhhospitals.org |
| Phone: | (216) 844-6170 |
Association Between Perioperative Bleeding and Aspirin Use in Spine Surgery: A Randomized, Controlled Trial
The investigators would like to further the current understanding of aspirin and its effects
on perioperative bleeding by conducting a randomized controlled trial of spinal surgery
patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators
hypothesize that there will be no significant difference in perioperative blood loss between
the different groups.
on perioperative bleeding by conducting a randomized controlled trial of spinal surgery
patients receiving varying doses of aspirin or no aspirin perioperatively. The investigators
hypothesize that there will be no significant difference in perioperative blood loss between
the different groups.
Selected patients will be given either no aspirin, low-dose aspirin (81 mg), or high-dose
aspirin (325 mg) in the perioperative period. These dosages are based on the Pharmacist's
letter/Prescriber's letter which provides aspirin dosing recommendations for varying
cardiovascular indications. Allocation of dosing will be based on computerized randomization
in order to achieve approximately 100 patients in each group. Patient records will then be
assessed for demographic characteristics, comorbidities, symptoms, functional outcome scores
(Sf-12), operative time, intraoperative estimated blood loss, postoperative blood loss in
drainage tubes (when applicable), cumulative blood loss, transfusion of blood products,
hemoglobin level, preoperative International Normalized Ratio (INR), preoperative platelet
count, hospital length of stay, and morbidity and mortality including development of NSTEMI,
atrial fibrillation, surgical site infection, pulmonary embolism, and hospital 30-day
readmission rates.
aspirin (325 mg) in the perioperative period. These dosages are based on the Pharmacist's
letter/Prescriber's letter which provides aspirin dosing recommendations for varying
cardiovascular indications. Allocation of dosing will be based on computerized randomization
in order to achieve approximately 100 patients in each group. Patient records will then be
assessed for demographic characteristics, comorbidities, symptoms, functional outcome scores
(Sf-12), operative time, intraoperative estimated blood loss, postoperative blood loss in
drainage tubes (when applicable), cumulative blood loss, transfusion of blood products,
hemoglobin level, preoperative International Normalized Ratio (INR), preoperative platelet
count, hospital length of stay, and morbidity and mortality including development of NSTEMI,
atrial fibrillation, surgical site infection, pulmonary embolism, and hospital 30-day
readmission rates.
Inclusion Criteria:
- All patients over 18 years old, who are not taking aspirin at the time of operation
as part of a current cardiovascular treatment plan, who will undergo spinal surgery
from 2016-2019 in the practice of Dr. Eubanks.
Exclusion Criteria:
- Any patient under the age of 18 and/or is already taking anticoagulant therapy for an
established cardiovascular disease at the time of surgery as part of a cardiovascular
therapy.
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