Perioperative Bleeding and Aspirin Use in Spine Surgery

NCT ID: NCT02807441

Last Updated: 2021-10-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Hemorrhage; Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

No aspirin

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low-dose aspirin

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

Group Type: EXPERIMENTAL

Acetylsalicylic acid

Intervention Type: DRUG

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

High-dose aspirin

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

Group Type: EXPERIMENTAL

Acetylsalicylic acid

Intervention Type: DRUG

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

Interventions

Acetylsalicylic acid

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

Intervention Type: DRUG

Other Intervention Names

aspirin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Heather Fuhrman

medical student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Eubanks, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21212258 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26030214 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22470078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25757534 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25695574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23615883 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24740280 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21474081 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26620144 (View on PubMed)

Other Identifiers

UHCMC-Ortho

Identifier Type: -

Identifier Source: org_study_id