Femoral FracturesPhase 4NCT00824564
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
A Phase 4 study of Femoral Fractures, run by Pfizer at 1 site in India.
Trial summary
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoral Fractures
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing surgery for fracture shaft of femur
Who cannot join
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
- Patients with known coagulopathy
- Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)
- Patients with documented DVT or PE at screening or in past three months
- Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
- Patients with any associated major illness (e.g., severe cardiac or respiratory disease)
- Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.
- Conditions
- Femoral Fractures
- Being tested
- Tranexamic Acid plus standard of care, Standard of care
- Keywords
- Tranexamic Acid, Blood Loss, Long Bone Fracture Surgery
- Medical subject headings
- Femoral Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid plus standard of careDrug
Tranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss)
Standard of careProcedure or surgery
Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Tranexamic Acid plus standard of care Receives: Drug: Tranexamic Acid plus standard of care |
| B | Other | Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss. Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Loss
Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: Baseline through Day 7 post-surgery
Secondary outcomes (6)
Intra-operative Blood Loss
Intra-operative blood loss was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: Day 1 (End of surgery)
Post-operative Blood Loss
Post-operative blood loss was defined as the sum of the drainage volumes measured over post-operative days 1, 2, and at drain removal. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
Measured: 1, 4, 8 and 24 hours post-surgery
Total Blood Loss Assessed by Gross' Formula
Gross's formula for estimating total blood loss: Estimated blood volume*[(Hematocrit initial - Hematocrit final)/ Hematocrit average]; where estimated blood volume equals body weight in kilograms (kg) *70 mL/kg.
Measured: Day 7 post-surgery
Number of Participants Receiving Transfusions
A uniform transfusion protocol was maintained for all participants in the study. Transfusion to be triggered at 8.0 milligram/deciliter (mg/dl) hemoglobin or haematocrit value of 24 percent.
Measured: Up to day 7 post-surgery
Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery
Measured: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery
Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
DVT was defined if a segment of the deep vein of the lower limb was not compressible or a previous compressive vein became non compressive or there was no flow in the underlying vessel. Symptoms of DVT included pain in the lower limb, localized tenderness, swelling and warmth.
Measured: Day 5 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824564
- Sponsor's protocol ID
- B1461002
- Status last verified
- Jun 2011
- First submitted
- 14 Jan 2009
- Last updated
- 28 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
- ClinicalTrials.gov ID
- NCT00824564
- Acronym / sponsor ID
- B1461002
- Conditions
- Femoral Fractures
- Keywords
- Tranexamic Acid, Blood Loss, Long Bone Fracture Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 28 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Tranexamic Acid plus standard of careTranexamic Acid plus standard of care |
| B | Other | Procedure: Standard of careStandard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient undergoing surgery for fracture shaft of femur
Key exclusion criteria (7 listed)
- Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
- Patients with known coagulopathy
- Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit <24%)
- Patients with documented DVT or PE at screening or in past three months
- Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
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 |
|---|---|---|
| Tranexamic Acid plus standard of careTranexamic acid given slowly intravenously (15 mg/kg body weight) 15 minutes before surgery followed by a second dose at three hour interval from first dose and third dose at three hour interval from the second + Standard of care (Standard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss) | Drug | A |
| Standard of careStandard of care includes the routine surgical and anesthetic techniques being utilized to control blood loss | Procedure or surgery | B |
Primary outcome
Total Blood Loss
Time frame: Baseline through Day 7 post-surgery
Total blood loss was defined as the sum of intra-operative and post-operative blood loss. It was measured by weighing the drapes/ dressings or swabs prior to soaking to measure difference in weight and checking drain collectors until drains were removed.
6 secondary outcomes
Intra-operative Blood Loss
Time frame: Day 1 (End of surgery)
Post-operative Blood Loss
Time frame: 1, 4, 8 and 24 hours post-surgery
Total Blood Loss Assessed by Gross' Formula
Time frame: Day 7 post-surgery
Number of Participants Receiving Transfusions
Time frame: Up to day 7 post-surgery
Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery
Time frame: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery
Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
Time frame: Day 5 post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 of Femoral Fractures, run by Pfizer at 1 site in India.
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 7 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 28 Jun 2011. 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 India. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Blood Loss (time frame: Baseline through Day 7 post-surgery). 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 28 Jun 2011.