Perioperative Bleeding and Aspirin Use in Spine Surgery (ASA)

October 3, 2021 updated by: Heather Fuhrman, University Hospitals Cleveland Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhage: Amount of blood loss
Time Frame: Intraoperative
Amount of blood loss from the operation will be recorded
Intraoperative
Hemorrhage: Amount of blood loss
Time Frame: 48 hours Postoperative
Blood loss from drainage tube when applicable
48 hours Postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Transfusion: Amount of blood products transfused
Time Frame: Intraoperative
Amount of blood products transfused when applicable
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Jason Eubanks, MD, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (ESTIMATE)

June 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 11, 2021

Last Update Submitted That Met QC Criteria

October 3, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCMC-Ortho

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhage

Clinical Trials on Acetylsalicylic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe