Hand SurgeryNCT00954928
The Safety of Hand Surgery in the Anticoagulated Patient
An observational study of Hand Surgery, run by Washington University School of Medicine at 1 site in United States.
Trial summary
If operating on the anticoagulated patient has been safe for one of the investigators' surgeons for the past 10 years then providing prospective data that substantiates this could prevent complications related to the discontinuation of anticoagulation for hand surgery patients in the future. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Surgery
- How many people
- 398 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults over 18 years of age having hand surgery while on anti-coagulant medication. Control subjects undergoing hand and wrist surgery without anticoagulant medications will be enrolled if they are over 18 years of age and able to consent to research participation. Patients on Coumadin with INR values less than or equal to 3.5 will be eligible for study inclusion.
Who may be able to join
- Adults over 18 years of age
- Taking daily anti-coagulant medication
- Having hand or wrist surgery
Who cannot join
- Surgery proximal to wrist
- Pregnant females
- INR > 3.5
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
If operating on the anticoagulated patient has been safe for one of the investigators' surgeons for the past 10 years then providing prospective data that substantiates this could prevent complications related to the discontinuation of anticoagulation for hand surgery patients in the future.
Read the detailed description
All eligible patients will be offered study enrollment pre-operatively. Demographic data collected during clinical interaction that will be gathered for research purposes and will included patient height, weight, age, anticoagulant medication(s) used with dosage/duration of use, indication for anticoagulant medication, and current INR if on warfarin. Preoperative examination will include measures of 2 point discrimination in the digits, distance of the fingertips from the distal palmar crease upon flexion, and the patient-based outcome surveys that are to be collected after surgery (Quick DASH, SF-12, Visual Analog Scales pain/swelling). These patients will then undergo the appropriate surgical procedure without discontinuing their anticoagulant medication.
To ensure that patients are not being placed at increased risk, this study's protocol will not alter the surgical practices of the attending surgeons involved. Specifically, all surgeons perform their hand and wrist surgery under tourniquet control but differ in whether the tourniquet is deflated prior to wound closure. Each surgeon will be free to manage the tourniquet as they feel appropriate. The placement of would drains will remain at the discretion of the attending surgeon on a case-by-case basis.
Local anesthetics may be injected but none will be mixed with epinephrine.
Procedures: (if applicable) Obtaining pre-operative INR values when appropriate, and performing surgery while continuing anticoagulants is already standard care for one faculty member. All post-operative care except the completion of the Quick DASH and Short Form 12, and visual analog ratings is part of standard clinical care. Research questionnaires should take no more than 20 minutes to complete per visit.
- Conditions
- Hand Surgery
- Keywords
- hand, wrist, anticoagulation, surgery, patients on anticoagulant medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulated patients | Those patients taking Coumadin, Plavix, Aspirin, Lovenox. | |
| Control patients | Those patients having hand or wrist surgery who do not take any anticoagulant medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hematoma
Measured: 2 week, 4 week
Secondary outcomes (5)
2 point discrimination
Measured: 2 week, 4 week
patient rated pain
Measured: 2 week, 4 week
patient rated function
Measured: 2 week, 4 week
ecchymosis
Measured: 2week , 4 week
joint range of motion
Measured: 2 week, 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand SurgeryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Calfee, MD, Washington University School of Medicine
- Investigators
- Ryan Calfee, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954928
- Sponsor's protocol ID
- 09-0567
- Status last verified
- Jun 2015
- First submitted
- 5 Aug 2009
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindsley RC. Perioperative management of systemic oral anticoagulants in patients having outpatient hand surgery. J Hand Surg Am. 2008 Sep;33(7):1205-7. doi: 10.1016/j.jhsa.2008.05.026.
PubMed 18762121
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Hand Surgery in the Anticoagulated Patient
- ClinicalTrials.gov ID
- NCT00954928
- Acronym / sponsor ID
- 09-0567
- Conditions
- Hand Surgery
- Keywords
- hand, wrist, anticoagulation, surgery, patients on anticoagulant medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 7 Aug 2009 (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.
If operating on the anticoagulated patient has been safe for one of the investigators' surgeons for the past 10 years then providing prospective data that substantiates this could prevent complications related to the discontinuation of anticoagulation for hand surgery patients in the future.
Detailed description
All eligible patients will be offered study enrollment pre-operatively. Demographic data collected during clinical interaction that will be gathered for research purposes and will included patient height, weight, age, anticoagulant medication(s) used with dosage/duration of use, indication for anticoagulant medication, and current INR if on warfarin. Preoperative examination will include measures of 2 point discrimination in the digits, distance of the fingertips from the distal palmar crease upon flexion, and the patient-based outcome surveys that are to be collected after surgery (Quick DASH, SF-12, Visual Analog Scales pain/swelling). These patients will then undergo the appropriate surgical procedure without discontinuing their anticoagulant medication.
To ensure that patients are not being placed at increased risk, this study's protocol will not alter the surgical practices of the attending surgeons involved. Specifically, all surgeons perform their hand and wrist surgery under tourniquet control but differ in whether the tourniquet is deflated prior to wound closure. Each surgeon will be free to manage the tourniquet as they feel appropriate. The placement of would drains will remain at the discretion of the attending surgeon on a case-by-case basis.
Local anesthetics may be injected but none will be mixed with epinephrine.
Procedures: (if applicable) Obtaining pre-operative INR values when appropriate, and performing surgery while continuing anticoagulants is already standard care for one faculty member. All post-operative care except the completion of the Quick DASH and Short Form 12, and visual analog ratings is part of standard clinical care. Research questionnaires should take no more than 20 minutes to complete per visit.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anticoagulated patients | – | –Those patients taking Coumadin, Plavix, Aspirin, Lovenox. |
| Control patients | – | –Those patients having hand or wrist surgery who do not take any anticoagulant medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 18 years of age having hand surgery while on anti-coagulant medication. Control subjects undergoing hand and wrist surgery without anticoagulant medications will be enrolled if they are over 18 years of age and able to consent to research participation. Patients on Coumadin with INR values less than or equal to 3.5 will be eligible for study inclusion.
Key inclusion criteria (3 listed)
- Adults over 18 years of age
- Taking daily anti-coagulant medication
- Having hand or wrist surgery
Key exclusion criteria (3 listed)
- Surgery proximal to wrist
- Pregnant females
- INR > 3.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative hematoma
Time frame: 2 week, 4 week
5 secondary outcomes
2 point discrimination
Time frame: 2 week, 4 week
patient rated pain
Time frame: 2 week, 4 week
patient rated function
Time frame: 2 week, 4 week
ecchymosis
Time frame: 2week , 4 week
joint range of motion
Time frame: 2 week, 4 week
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 29 Jun 2015.
- Background: PubMed 18762121Lindsley RC. Perioperative management of systemic oral anticoagulants in patients having outpatient hand surgery. J Hand Surg Am. 2008 Sep;33(7):1205-7. doi: 10.1016/j.jhsa.2008.05.026.
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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.
Ryan Calfee, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Surgery, run by Washington University School of Medicine at 1 site in United States.
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 3 inclusion and 3 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 29 Jun 2015. 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 United States. 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.
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?
postoperative hematoma (time frame: 2 week, 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954928, which also lists 1 linked publication.
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 29 Jun 2015.