DVTPhase 4NCT00253851
Does Thinning the Blood During Surgery Prevent Blood Clots Following Total Knee Replacement Surgery
A Phase 4 study testing unfractionated heparin in people with DVT and Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- DVT, Osteoarthritis
- What is being tested?
- unfractionated heparin
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2003to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1) 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre, Double-blind, Randomized, Controlled Trial Comparing Intra-operative Regional Heparinization to Placebo for the Prevention of Deep Vein Thrombosis Following Total Knee Arthroplasty
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.
Read the detailed description
Venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins intra-operatively then targeting this period to prevent clot formation could substantially reduce DVT rates in the TKA population. The present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of DVT following TKA, as evidenced by venography in the early post-operative period.
- Conditions
- DVT, Osteoarthritis
- Being tested
- unfractionated heparin
- Keywords
- DVT, Osteoarthritis, Total Knee Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unfractionated heparinDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
DVT as determined by venography
Measured: 5 day post op
Secondary outcomes (1)
Bleeding rate Rate of PE Complication Rate
Measured: 2 week post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startJul 2003
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DVTStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A Giachino, Principal investigator, OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253851
- Sponsor's protocol ID
- OHREB 2002597-01H
- Status last verified
- Apr 2012
- First submitted
- 10 Nov 2005
- Last updated
- 17 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Double-blind, Randomized, Controlled Trial Comparing Intra-operative Regional Heparinization to Placebo for the Prevention of Deep Vein Thrombosis Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00253851
- Acronym / sponsor ID
- OHREB 2002597-01H
- Conditions
- DVT, Osteoarthritis
- Keywords
- DVT, Osteoarthritis, Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. If, as suggested, DVT formation begins intra-operatively then targeting this period to prevent clot formation could substantially reduce DVT rates in the TKA population. The present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of DVT following TKA, as evidenced by venography in the early post-operative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unfractionated heparinFive 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. | Drug | – |
Primary outcome
DVT as determined by venography
Time frame: 5 day post op
1 secondary outcome
Bleeding rate Rate of PE Complication Rate
Time frame: 2 week post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Giachino principal investigator
OHRI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing unfractionated heparin in people with DVT and Osteoarthritis, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DVT as determined by venography (time frame: 5 day post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2012.