NCT02807441

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

June 14, 2016

Last Update Submit

October 3, 2021

Conditions

HemorrhageThrombosis

Keywords

BleedingAspirinSpineSurgery

Outcome Measures

Primary Outcomes (2)

  • Hemorrhage: Amount of blood loss

    Amount of blood loss from the operation will be recorded

    Intraoperative

  • Hemorrhage: Amount of blood loss

    Blood loss from drainage tube when applicable

    48 hours Postoperative

Secondary Outcomes (1)

  • Blood Transfusion: Amount of blood products transfused

    Intraoperative

Study Arms (3)

No aspirin

NO INTERVENTION

Patients will not be given any Acetylsalicylic acid in the perioperative period.

Low-dose aspirin

EXPERIMENTAL

Patients will be given low-dose Acetylsalicylic acid (81 mg) in the perioperative period.

Drug: Acetylsalicylic acid

High-dose aspirin

EXPERIMENTAL

Patients will be given high-dose Acetylsalicylic acid (325 mg) in the perioperative period.

Drug: Acetylsalicylic acid

Interventions

Acetylsalicylic acidDRUG

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

Also known as: aspirin
High-dose aspirinLow-dose aspirin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (9)

  • 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.

    PMID: 21212258BACKGROUND

  • 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.

    PMID: 26030214BACKGROUND

  • 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.

    PMID: 22470078BACKGROUND

  • 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.

    PMID: 25757534BACKGROUND

  • 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.

    PMID: 25695574BACKGROUND

  • 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.

    PMID: 23615883BACKGROUND

  • 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.

    PMID: 24740280BACKGROUND

  • 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.

    PMID: 21474081BACKGROUND

  • 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.

    PMID: 26620144BACKGROUND

MeSH Terms

Conditions

HemorrhageThrombosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Jason Eubanks, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical student

Study Record Dates

First Submitted

June 14, 2016

First Posted

June 21, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

October 11, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)