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Perioperative Bleeding and Aspirin Use in Spine Surgery (ASA)

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ClinicalTrials.gov Identifier: NCT02807441
Recruitment Status : Not yet recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Heather Fuhrman, University Hospitals Cleveland Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemorrhage Thrombosis Drug: Acetylsalicylic acid Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Association Between Perioperative Bleeding and Aspirin Use in Spine Surgery: A Randomized, Controlled Trial
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Aspirin

Arm Intervention/treatment
No Intervention: No aspirin
Patients will not be given any Acetylsalicylic acid in the perioperative period.
Experimental: Low-dose aspirin
Patients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period.
Drug: Acetylsalicylic acid
Patients will receive different doses of aspirin perioperatively to assess bleeding association.
Other Name: aspirin

Experimental: High-dose aspirin
Patients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period.
Drug: Acetylsalicylic acid
Patients will receive different doses of aspirin perioperatively to assess bleeding association.
Other Name: aspirin




Primary Outcome Measures :
  1. Hemorrhage: Amount of blood loss [ Time Frame: Intraoperative ]
    Amount of blood loss from the operation will be recorded

  2. Hemorrhage: Amount of blood loss [ Time Frame: 48 hours Postoperative ]
    Blood loss from drainage tube when applicable


Secondary Outcome Measures :
  1. Blood Transfusion: Amount of blood products transfused [ Time Frame: Intraoperative ]
    Amount of blood products transfused when applicable



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807441


Contacts
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Contact: Jason Eubanks, MD (216) 844-6170 Jason.Eubanks@uhhospitals.org
Contact: Heather Fuhrman, BS, BA 2013643783 haf30@case.edu

Locations
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United States, Ohio
University Hospitals Case Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Jason Eubanks, MD    216-844-6170    Jason.Eubanks@uhhospitals.org   
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Jason Eubanks, MD University Hospitals Cleveland Medical Center

Publications:

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Responsible Party: Heather Fuhrman, Medical Student, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02807441     History of Changes
Other Study ID Numbers: UHCMC-Ortho
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be collected on a computer database containing unique identifiers, without names, social security numbers, medical record numbers, or other information that could be used to identify individuals. University Hospitals Research Electronic Data Capture will be used as a means of secure data storage. At no time will this data spreadsheet be printed or otherwise distributed, and no Protected Health Information will be transferred to investigators at other sites of this multi-center study.

Keywords provided by Heather Fuhrman, University Hospitals Cleveland Medical Center:
Bleeding
Aspirin
Spine
Surgery

Additional relevant MeSH terms:
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Aspirin
Hemorrhage
Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics