Orthopedic Procedures, Tranexamic AcidNCT02373969
Thromboelastogram During Total Knee Replacement
An observational study of Orthopedic Procedures, Tranexamic Acid, run by Rambam Health Care Campus.
Trial summary
Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Orthopedic Procedures, Tranexamic Acid
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jan 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As described in eligibility criteria
Who may be able to join
- Osteoarthrosis
- TKR operation elective
- ASA I-III
Who cannot join
- TKR due to any reason but osteoarthrosis
- known coagulation problems
- platelets < 100,000/DcL
- Hb < 12 g%
- past thrombo-embolic event
- treatment with aspiring during last week
Show all 10Show fewer
- treatment with NSAID's during last 48 hours
- malignancy
- known allergy to tranexamic acid
- general anesthesia
About this study
Official title: Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid
Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.
Read the detailed description
The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.
- Conditions
- Orthopedic Procedures, Tranexamic Acid
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in coagulation status during and after surgery compared to pre-surgery
Measured: During and after surgery compared to pre-surgery
Change in fibrinolytic activity during and after surgery compared to pre-surgery
Measured: During and after surgery compared to pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic Procedures, Tranexamic AcidStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373969
- Sponsor's protocol ID
- TEG-099-11
- Status last verified
- Apr 2016
- First submitted
- 22 Feb 2015
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastogram During Surgery for Total Knee Replacement With Tourniquet Application and Single Dose Tranexamic Acid
- ClinicalTrials.gov ID
- NCT02373969
- Acronym / sponsor ID
- TEG-099-11
- Conditions
- Orthopedic Procedures, Tranexamic Acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Feb 2015 (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.
Verify the changes in coagulation system during total knee replacement surgery with tranexamic acid single bolus infusion.
Detailed description
The study was set to reveal changes in the coagulation and fibrinolytic systems during total knee surgery and especially during tourniquet placement, tourniquet removal and revascularization of ischemic limb, after tranexamic acid single bolus infusion, and at post operative day 1.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As described in eligibility criteria
Key inclusion criteria (3 listed)
- Osteoarthrosis
- TKR operation elective
- ASA I-III
Key exclusion criteria (10 listed)
- TKR due to any reason but osteoarthrosis
- known coagulation problems
- platelets < 100,000/DcL
- Hb < 12 g%
- past thrombo-embolic event
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
Change in coagulation status during and after surgery compared to pre-surgery
Time frame: During and after surgery compared to pre-surgery
Change in fibrinolytic activity during and after surgery compared to pre-surgery
Time frame: During and after surgery compared to pre-surgery
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 6 Apr 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Procedures, Tranexamic Acid, run by Rambam Health Care Campus.
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 10 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in coagulation status during and after surgery compared to pre-surgery (time frame: During and after surgery compared to pre-surgery). The study lists 2 primary outcomes in all. 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 6 Apr 2016.