Prospective Study Investigating Aspirin and Intraoperative Blood Loss and Complications Following Inguinal Hernia Repair

NCT02084615 | Unknown

• 1 other identifier: 2013-0976
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether aspirin taken in the perioperative period will increase the blood loss associated with open inguinal hernia repairs. A secondary purpose of this study is to determine if the aspirin administered in the perioperative period increases the risk of complications associated with open inguinal hernia repairs.

Conditions

Hernia, Inguinal; Postoperative Complications; Postoperative Hemorrhage

Keywords

Aspirin; Postoperative hemorrhage; Inguinal hernia

Outcome Measures

Primary Outcomes (1)

• intraoperative blood loss

  intraoperative blood loss will be accurately measured among the three arms of the study

  intraoperative only

Secondary Outcomes (1)

• Number of Participants with Serious and Non-Serious Adverse Events

  30 days post operative

Study Arms (2)

81mg aspirin

EXPERIMENTAL

This arm will include perioperative 81 mg of aspirin.

Drug: Aspirin

325mg aspirin

EXPERIMENTAL

Subjects will be taking 325mg of aspirin.

Drug: Aspirin

Interventions

Aspirin DRUG

Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin

Also known as: acetylsalicylic acid

325mg aspirin; 81mg aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult male veterans ages 18-99
• inguinal hernia
• subjects currently taking 81mg, 325mg or no aspirin

You may not qualify if:

• recurrent hernia
• "giant" hernia
• women
• International Normalized Ratio \> 1.7
• Hemophilia or other know congenital bleeding disorder
• Cirrhosis of hepatitis with coagulopathy
• Thrombocytopenia with platelet counts \< 100,000
• Subjects currently on Coumadin or other platelet inhibitors

Sponsors & Collaborators

• Jesse Brown VA Medical Center: lead

Study Sites (1)

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (13)

• Antolovic D, Rakow A, Contin P, Ulrich A, Rahbari NN, Buchler MW, Weitz J, Koch M. A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007). Langenbecks Arch Surg. 2012 Feb;397(2):297-306. doi: 10.1007/s00423-011-0867-7. Epub 2011 Nov 3.

  PMID: 22048442 BACKGROUND

• Binhas M, Salomon L, Roudot-Thoraval F, Armand C, Plaud B, Marty J. Radical prostatectomy with robot-assisted radical prostatectomy and laparoscopic radical prostatectomy under low-dose aspirin does not significantly increase blood loss. Urology. 2012 Mar;79(3):591-5. doi: 10.1016/j.urology.2011.11.031.

  PMID: 22386405 BACKGROUND

• Burger W, Chemnitius JM, Kneissl GD, Rucker G. Low-dose aspirin for secondary cardiovascular prevention - cardiovascular risks after its perioperative withdrawal versus bleeding risks with its continuation - review and meta-analysis. J Intern Med. 2005 May;257(5):399-414. doi: 10.1111/j.1365-2796.2005.01477.x.

  PMID: 15836656 BACKGROUND

• Chechik O, Goldstein Y, Behrbalk E, Kaufman E, Rabinovich Y. Blood loss and complications following carotid endarterectomy in patients treated with clopidogrel. Vascular. 2012 Aug;20(4):193-7. doi: 10.1258/vasc.2011.oa0336. Epub 2012 May 10.

  PMID: 22577162 BACKGROUND

• 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: 22470078 BACKGROUND

• 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: 21474081 BACKGROUND

• Leyh-Bannurah SR, Hansen J, Isbarn H, Steuber T, Tennstedt P, Michl U, Schlomm T, Haese A, Heinzer H, Huland H, Graefen M, Budaus L. Open and robot-assisted radical retropubic prostatectomy in men receiving ongoing low-dose aspirin medication: revisiting an old paradigm? BJU Int. 2014 Sep;114(3):396-403. doi: 10.1111/bju.12504. Epub 2014 Jul 15.

  PMID: 24127902 BACKGROUND

• Madan GA, Madan SG, Madan G, Madan AD. Minor oral surgery without stopping daily low-dose aspirin therapy: a study of 51 patients. J Oral Maxillofac Surg. 2005 Sep;63(9):1262-5. doi: 10.1016/j.joms.2005.05.164.

  PMID: 16122588 BACKGROUND

• Manning BJ, O'Brien N, Aravindan S, Cahill RA, McGreal G, Redmond HP. The effect of aspirin on blood loss and transfusion requirements in patients with femoral neck fractures. Injury. 2004 Feb;35(2):121-4. doi: 10.1016/s0020-1383(03)00073-1.

  PMID: 14736467 BACKGROUND

• Ono K, Idani H, Hidaka H, Kusudo K, Koyama Y, Taguchi S. Effect of aspirin continuation on blood loss and postoperative morbidity in patients undergoing laparoscopic cholecystectomy or colorectal cancer resection. Surg Laparosc Endosc Percutan Tech. 2013 Feb;23(1):97-100. doi: 10.1097/SLE.0b013e318278cdf8.

  PMID: 23386161 BACKGROUND

• Oscarsson A, Gupta A, Fredrikson M, Jarhult J, Nystrom M, Pettersson E, Darvish B, Krook H, Swahn E, Eintrei C. To continue or discontinue aspirin in the perioperative period: a randomized, controlled clinical trial. Br J Anaesth. 2010 Mar;104(3):305-12. doi: 10.1093/bja/aeq003.

  PMID: 20150346 BACKGROUND

• Partridge CG, Campbell JH, Alvarado F. The effect of platelet-altering medications on bleeding from minor oral surgery procedures. J Oral Maxillofac Surg. 2008 Jan;66(1):93-7. doi: 10.1016/j.joms.2005.11.055.

  PMID: 18083421 BACKGROUND

• Zigdon H, Levin L, Filatov M, Oettinger-Barak O, Machtei EE. Intraoperative bleeding during open flap debridement and regenerative periodontal surgery. J Periodontol. 2012 Jan;83(1):55-60. doi: 10.1902/jop.2011.110182. Epub 2011 May 12.

  PMID: 21563946 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Postoperative Complications; Postoperative Hemorrhage

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Hemorrhage

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Joseph M Vitello, MD

  Jesse Brown VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chief of Surgical Services

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 12, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

US (1)