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HemorrhagePhase 3ASANCT02807441

Perioperative Bleeding and Aspirin Use in Spine Surgery

A Phase 3 study testing Acetylsalicylic acid in people with Hemorrhage and Thrombosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hemorrhage, Thrombosis
What is being tested?
Acetylsalicylic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Jul 2016to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Acetylsalicylic acid
Keywords
Bleeding, Aspirin, Spine, Surgery
Medical subject headings
Hemorrhage, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acetylsalicylic acidDrug

    Also called aspirin

    Patients will receive different doses of aspirin perioperatively to assess bleeding association.

Study groups in NCT02807441
Study groupRoleWhat they receive
No aspirinNo interventionPatients will not be given any Acetylsalicylic acid in the perioperative period.
Low-dose aspirinExperimentalPatients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period.
Receives: Drug: Acetylsalicylic acid
High-dose aspirinExperimentalPatients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period.
Receives: Drug: Acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemorrhage: Amount of blood loss

    Amount of blood loss from the operation will be recorded

    Measured: Intraoperative

  2. Hemorrhage: Amount of blood loss

    Blood loss from drainage tube when applicable

    Measured: 48 hours Postoperative

Secondary outcomes (1)

  1. Blood Transfusion: Amount of blood products transfused

    Amount of blood products transfused when applicable

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJul 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02807441
Sponsor's protocol ID
UHCMC-Ortho
Acronym
ASA
Status last verified
Oct 2021
First submitted
14 Jun 2016
Last updated
11 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No: 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.

Publications

  • Hall R, Mazer CD. Antiplatelet drugs: a review of their pharmacology and management in the perioperative period. Anesth Analg. 2011 Feb;112(2):292-318. doi: 10.1213/ANE.0b013e318203f38d. Epub 2011 Jan 6.

    PubMed 21212258

  • Cuellar JM, Petrizzo A, Vaswani R, Goldstein JA, Bendo JA. Does aspirin administration increase perioperative morbidity in patients with cardiac stents undergoing spinal surgery? Spine (Phila Pa 1976). 2015 May 1;40(9):629-35. doi: 10.1097/BRS.0000000000000695.

    PubMed 26030214

  • Gerstein NS, Schulman PM, Gerstein WH, Petersen TR, Tawil I. Should more patients continue aspirin therapy perioperatively?: clinical impact of aspirin withdrawal syndrome. Ann Surg. 2012 May;255(5):811-9. doi: 10.1097/SLA.0b013e318250504e.

    PubMed 22470078

  • Soleman J, Baumgarten P, Perrig WN, Fandino J, Fathi AR. Non-instrumented extradural lumbar spine surgery under low-dose acetylsalicylic acid: a comparative risk analysis study. Eur Spine J. 2016 Mar;25(3):732-9. doi: 10.1007/s00586-015-3864-7. Epub 2015 Mar 11.

    PubMed 25757534

  • Gerstein NS, Carey MC, Cigarroa JE, Schulman PM. Perioperative aspirin management after POISE-2: some answers, but questions remain. Anesth Analg. 2015 Mar;120(3):570-575. doi: 10.1213/ANE.0000000000000589.

    PubMed 25695574

  • Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.

    PubMed 23615883

  • Park HJ, Kwon KY, Woo JH. Comparison of blood loss according to use of aspirin in lumbar fusion patients. Eur Spine J. 2014 Aug;23(8):1777-82. doi: 10.1007/s00586-014-3294-y. Epub 2014 Apr 17.

    PubMed 24740280

  • Kang SB, Cho KJ, Moon KH, Jung JH, Jung SJ. Does low-dose aspirin increase blood loss after spinal fusion surgery? Spine J. 2011 Apr;11(4):303-7. doi: 10.1016/j.spinee.2011.02.006.

    PubMed 21474081

  • Wong SS, Irwin MG. Peri-operative cardiac protection for non-cardiac surgery. Anaesthesia. 2016 Jan;71 Suppl 1:29-39. doi: 10.1111/anae.13305.

    PubMed 26620144

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetylsalicylic acid in people with Hemorrhage and Thrombosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemorrhage: Amount of blood loss (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02807441, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.

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