Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery

NCT00253851 | Completed Phase 4

• 1 other identifier: OHREB 2002597-01H
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to prevent blood clots from forming during surgery and a few days after total knee replacement surgery. This study will help us identify whether using a blood thinner in the operating room will stop blood clots from forming during the operation.

Conditions

DVT; Osteoarthritis

Keywords

DVT; Osteoarthritis; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• DVT as determined by venography

  5 day post op

Secondary Outcomes (1)

• Bleeding rate Rate of PE Complication Rate

  2 week post op

Interventions

unfractionated heparin DRUG

Five minutes prior to tourniquet inflation, patients will receive 0.1 ml/kg/minute of intravenous (IV) unfractionated heparin (1000 units/ml) or placebo (normal saline solution). Five minutes will be allowed to elapse to ensure complete systemic heparinization. The operated limb will then be elevated and exsanguinated using an Esmarch bandage. Following cuff inflation, the contents of a second syringe will be administered IV over a 5 minute period. The second syringe will contain either protamine sulfate (1.0 mg/kg) to reverse the systemic heparin for patients in the treatment group, or normal saline for the control group. Study drugs will be administered by the anaesthesiologist via a peripheral IV. This new method of intraoperative regional heparinization has been used in two previous studies (Giachino et al., 2001; Giachino et al., 1985) with no adverse effects noted.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing unilateral primary total knee arthroplasty
• Males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening)
• Full weight bearing status (of non-operated leg) following surgery
• Patient able to understand and willing to sign informed consent

You may not qualify if:

• \) Known hypersensitivity to contrast media 2) Patients taking Metformin 3) Serum creatinine above 180Fmol/L 4) Platelets \< 100 x 10 9/L, INR/PTT \> 1.5 x normal 5) History of heparin induced thrombocytopenia 6) Allergy to heparin or fish 7) Prior use of protamine sulfate (i.e., protamine-containing insulin) 8) Vasectomized or infertile males 9) History of bleeding disorder 10) Bilateral total knee arthroplasty 11) History of stroke or myocardial infarction in previous 6 months 12) Traumatic spinal anaesthesia (two or more attempts and/or bloody) 13) History of previous DVT/PE 14) Active peptic ulcer disease (e.g., GI bleed, rectal bleed) 15) Currently on chronic anticoagulant therapy 16) Contra-indication to heparin 17) Patient is taking part in any other investigational study 18) Previous contralateral TKR or hip replacement

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• A Giachino

  OHRI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 15, 2005
• Study Start: July 1, 2003
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

CA (1)