BleedingNCT00625248
Prospective Evaluation of Bleeding Risk of Anticoagulant and Anti-platelet Therapy
An observational study of Bleeding, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding
- What is being tested?
- Antithrombotics
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2010
- 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: ambulatory surgery center patients
Who may be able to join
- Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent.
Who cannot join
- All those things, patients on heparin, dextran, and low molecular heparin
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain Management Center of Paducah
Paducah, Kentucky, 42003
About this study
Official title: A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques
This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy
Read the detailed description
- To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy.
- To evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects.
- To evaluate and compare the adverse event profiling all patients.
- Conditions
- Bleeding
- Being tested
- Antithrombotics
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntithromboticsDrug
Also called anticoagulant or antiplatelet drugs
With or without or discontinuted use of Antithrombotics
| Study group | Role | What they receive |
|---|---|---|
| no anthithrombotic | procedures where there were no antithrombotics Receives: Drug: Antithrombotics | |
| Antithrombotic - continued | patients who are on antithrombotics Receives: Drug: Antithrombotics | |
| Discontinued Antithrombotic | Patients who were on antithrombotics but have been discontinued Receives: Drug: Antithrombotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.
Measured: 24 months
Secondary outcomes (1)
To assess adverse events in all patients.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Management Center of Paducah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
- Investigators
- Laxmaiah Manchikanti, MD, Principal investigator, Ambulatory Surgery Center, Paducah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625248
- Sponsor's protocol ID
- protocol 18
- Status last verified
- Jun 2013
- First submitted
- 19 Feb 2008
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manchikanti L, Malla Y, Wargo BW, Cash KA, McManus CD, Damron KS, Jackson SD, Pampati V, Fellows B. A prospective evaluation of bleeding risk of interventional techniques in chronic pain. Pain Physician. 2011 Jul-Aug;14(4):317-29.
PubMed 21785475Manchikanti L, Malla Y, Wargo BW, Fellows B. Infection control practices (safe injection and medication vial utilization) for interventional techniques: are they based on relative risk management or evidence? Pain Physician. 2011 Sep-Oct;14(5):425-34.
PubMed 21927046
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Bleeding Risk of Anticoagulant and Antiplatelet Therapy for Interventional Techniques
- ClinicalTrials.gov ID
- NCT00625248
- Acronym / sponsor ID
- protocol 18
- Conditions
- Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,000 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 28 Feb 2008 (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.
This study will evaluate bleeding risk and differences in outcomes in patients receiving and not receiving anticoagulant or antiplatelet therapy
Detailed description
- To evaluate bleeding risk in interventional procedures in patients with or without antiplatelet and/or anticoagulant therapy.
- To evaluate differences in outcomes in patients not receiving any anticoagulant or antiplatelet therapy compared to patients receiving various types of drugs with anticoagulant or antiplatelet therapeutic effects.
- To evaluate and compare the adverse event profiling all patients.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| no anthithrombotic | – | Drug: Antithromboticsprocedures where there were no antithrombotics |
| Antithrombotic - continued | – | Drug: Antithromboticspatients who are on antithrombotics |
| Discontinued Antithrombotic | – | Drug: AntithromboticsPatients who were on antithrombotics but have been discontinued |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ambulatory surgery center patients
Key inclusion criteria (1 listed)
- Subjects undergoing interventional techniques. Subjects who were able to give voluntary, written informed consent.
Key exclusion criteria (1 listed)
- All those things, patients on heparin, dextran, and low molecular heparin
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 |
|---|---|---|
| AntithromboticsAlso: anticoagulant or antiplatelet drugsWith or without or discontinuted use of Antithrombotics | Drug | Antithrombotic - continued, Discontinued Antithrombotic, no anthithrombotic |
Primary outcome
To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy.
Time frame: 24 months
1 secondary outcome
To assess adverse events in all patients.
Time frame: 24 months
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 24 Jun 2013.
- Results publication: PubMed 21785475Manchikanti L, Malla Y, Wargo BW, Cash KA, McManus CD, Damron KS, Jackson SD, Pampati V, Fellows B. A prospective evaluation of bleeding risk of interventional techniques in chronic pain. Pain Physician. 2011 Jul-Aug;14(4):317-29.
- Derived from this study: PubMed 21927046Manchikanti L, Malla Y, Wargo BW, Fellows B. Infection control practices (safe injection and medication vial utilization) for interventional techniques: are they based on relative risk management or evidence? Pain Physician. 2011 Sep-Oct;14(5):425-34.
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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.
Laxmaiah Manchikanti, MD principal investigator
Ambulatory Surgery Center, Paducah
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 Bleeding, run by Pain Management Center of Paducah 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 1 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 24 Jun 2013. 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?
To evaluate for differences between the patients undergoing interventional techniques with or without anticoagulant or antiplatelet therapy. (time frame: 24 months). 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 NCT00625248, which also lists 2 linked publications.
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 24 Jun 2013.