Perioperative Bleeding and Aspirin Use in Spine Surgery

Thrombosis Clinical Trial

— ASA  

Official title:

Association Between Perioperative Bleeding and Aspirin Use in Spine Surgery: A Randomized, Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02807441
• Other study ID #: UHCMC-Ortho
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2021
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The investigators hypothesize that there will be no significant difference in perioperative blood loss between the different groups.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Thrombosis

Intervention

Drug:
• Acetylsalicylic acid
Patients will receive different doses of aspirin perioperatively to assess bleeding association.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemorrhage: Amount of blood loss	Amount of blood loss from the operation will be recorded	Intraoperative
Primary	Hemorrhage: Amount of blood loss	Blood loss from drainage tube when applicable	48 hours Postoperative
Secondary	Blood Transfusion: Amount of blood products transfused	Amount of blood products transfused when applicable	Intraoperative