Pulmonary EmbolismDVTNCT00767559
Prophylaxis Against DVTs After Primary Hip and Knee Replacement Surgery
A study testing warfarin and Fondaparinux: in people with Pulmonary Embolism, run by The New England Baptist Hospital at 1 site in United States.
Trial summary
The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- warfarin and Fondaparinux:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Oct 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned for elective arthroplasty for knee and hip disease.
- Over 20 years of age.
- Normal baseline platelet count, prothrombin and partial thromboplastin times.
- Signed consent.
Who cannot join
- Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- Patients with personal history of TED, or documented hypercoagulation disease.
- Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
- Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
- Liver enzymes or bilirubin greater than 2 x normal.
- Decreased renal function with GFR < 30ml/min. (24-27)
Show all 12Show fewer
- Cancer in last 1 year, other than localized cancers of the skin.
- Requires chronic anticoagulation with warfarin or heparins.
- Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
- Prior adverse reaction to any of the study drugs.
- Pregnancy
- Uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Baptist Hospital
Boston, Massachusetts, 02120
About this study
Official title: Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities
The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.
Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.
Read the detailed description
Inclusion Criteria:
- Planned for elective primary arthroplasty for knee and hip disease at New England Baptist Hospital.
- Over 20 years of age.
- Normal baseline platelet count, prothrombin and partial thromboplastin times.
- Signed consent.
Exclusion Criteria:
- Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- Patients with personal history of TED, or documented hypercoagulation disease.
- Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
SPECIFIC AIMS:
This prospective, randomized study seeks to determine if there is an advantage for fixed, low dose of warfarin Thromboembolic Disease (TED) prophylaxis among patients undergoing elective lower extremity joint arthroplasty, as compared to variable dose warfarin and a low molecular weight heparin (LMWH). If confirmed as effective fixed, low dose warfarin would be an almost ideal prophylaxis against Deep Vein Thrombosis (DVT) and Pulmonary Embolus (PE): inexpensive, easy to administer, with minimal hemorrhagic potential, needing minimal laboratory support .
BACKGROUND AND SIGNIFICANCE:
A progression of studies has been performed to examine the efficacy of low dose warfarin. These studies demonstrated that low dose warfarin has antithrombotic activity, with little anticoagulant effect. Critical to this approach that the warfarin therapy be initiated prior to surgery. A summary of other studies offering supportive or conflicting data is available. (1-9)
- Low dose warfarin (2mg) dampens activated coagulation. (1-3)
- Two-step low dose warfarin begun 10-14 days pre-op is effective prophylaxis. (4)
- Low dose warfarin (1mg) prevents DVT's surrounding central venous catheters when started 3 days before catheter insertion among patients at very high risk for subclavian DVT. (5,6)
- Low dose warfarin (1mg) started 7 days prior to surgery is equal to variable dose warfarin for TED prophylaxis following hip arthroplasty. (7)
- Low dose warfarin (1mg) started 7 days prior to surgery is effective TED prophylaxis for patients having hip replacement arthroplasties in retrospective study of 1003 patients. (8)
The sentinel study used a fixed low dose warfarin regimen given to patients at extreme risk for DVT. Patients requiring central venous catheters for chemotherapy for metastatic cancer participated in a randomized study of 0.0 mg vs.1.0 mg daily warfarin starting 3 days prior to catheter placement. Subclavian vein venograms were performed at the time of symptoms of subclavian vein DVT or after 90 days. When using this low dose warfarin schedule there was a reduction in the incidence of thrombosis from 37.5% to 9.5%. (p<0.05) Four patients acquired vitamin K-responsive prolongation of the PT due to concomitant advanced liver disease and/or malnutrition. Concentrations of factors II, VII, IX, X, and protein C showed no difference between treated and untreated patients. (5)
Two orthopedic surgery studies from NEBH on this question have been published. (7,8) The first was a pilot study of 100 patients demonstrated no difference between the effectiveness of low fixed dose and variable dose warfarin in a population of patients at high risk for TED (7) Patients studied were planning total hip replacement arthroplasty were randomized between the standard regimens using warfarin of 5 mg the night prior to surgery followed by variable dose (target PT 1.3 - 1.5 times normal) for 30-45 days, or the experimental regimen using 1 mg beginning 7 days prior to surgery and continued until follow up at 30-45 days. Ultrasounds of the deep veins of the legs were performed at baseline, at discharge following surgery, and at 30-45 day follow-up. There was no difference between the groups for incidence of venous thrombosis. The second study was a retrospective study of patients undergoing primary (833) or revision (170) hip replacement arthroplasty receiving 1 mg warfarin for 7 days before surgery, variable dose while in hospital, (INR target 1.5 - 2.0) followed by 1 mg daily until follow-up at 30-45 days. (8) Each patient used pneumatic followed by elastic compression stockings. Of these 1003 patients, with 9 lost to follow-up. Three patients had TED, including 1 PE and 2 DVT.
- Conditions
- Pulmonary Embolism
- Being tested
- warfarin, Fondaparinux:
- Keywords
- Deep Vein Thrombosis, anticoagulants, surgery, pulmonary embolus, warfarin, fondaparinox
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
warfarinDrug
Also called Coumadin
5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 28 (+/-2 days) from day of surgery follow-up. (target INR 2.0 -2.5)
Fondaparinux:Drug
Also called Arixtra
2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*, or 6-8 hours after epidural catheter removal, and continued until follow up day 28 (+/-2 days) from day of surgery.
warfarinDrug
Also called coumadin
Fixed Low Dose warfarin
1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until follow-up 28 day (+/- 2 days) from day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Variable dose warfarin: 5 mg beginning the night before surgery, followed by 5mg the PM of surgery*, and then variable daily dose,until day 30 follow-up.
(target INR 2.0-2.5) Receives: Drug: warfarin |
| 2 | Active comparator | Fondaparinux:
2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*,or 6-8 hours after epidural catheter removal, and continued until follow-up (28 days +/-2) from day of surgery. Receives: Drug: Fondaparinux: |
| 3 | Active comparator | Fixed Low Dose warfarin
1 mg daily beginning 7 days preoperative, and continued at 1 mg daily follow-up at Day 28 (+/-2 days from surgery). Receives: Drug: warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome based upon intent to treat: Composite outcome of
Measured: 28 days
Ultrasound or venogram confirmed deep vein thrombosis.
Measured: 28 days
Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.
Measured: 28 days
Death due to TED
Measured: 28 days
Secondary outcomes (10)
Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures
Measured: 28 days
Distribution of proximal vs distal deep vein thrombosis of the leg
Measured: 28 days
Amount of intraoperative bleeding
Measured: follow until Dec. 31, 2010
Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events.
Measured: follow until Dec. 31, 2010
Number of ultrasounds and V/Q or CTA's required
Measured: follow until Dec. 31, 2010
Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications
Measured: follow until Dec. 31, 2010
Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit.
Measured: follow until Dec. 31, 2010
Death due to any other cause than TED
Measured: follow until Dec. 31, 2010
Use of low molecular weight dextran
Measured: follow until Dec. 31, 2010
Use of nonsteroidal anti-inflammatory drugs
Measured: follow until Dec. 31, 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
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 Pulmonary EmbolismStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Murray Bern, MD, Principal investigator, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767559
- Sponsor's protocol ID
- NEBH 2008-016
- Acronym
- DVT
- Status last verified
- Sep 2011
- First submitted
- 3 Oct 2008
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bern MM, Hazel D, Deeran E, Richmond JR, Ward DM, Spitz DJ, Mattingly DA, Bono JV, Berezin RH, Hou L, Miley GB, Bierbaum BE. Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study. Thromb J. 2015 Oct 7;13:32. doi: 10.1186/s12959-015-0062-0. eCollection 2015.
PubMed 26448724Bern MM, Hazel D, Reilly DT, Adcock DM, Hou L. Effects of anticoagulation on markers of activation of clotting following major orthopedic surgery. Int J Lab Hematol. 2015 Oct;37(5):673-9. doi: 10.1111/ijlh.12384. Epub 2015 May 15.
PubMed 25975205
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities
- ClinicalTrials.gov ID
- NCT00767559
- Acronym / sponsor ID
- DVT / NEBH 2008-016
- Conditions
- Pulmonary Embolism
- Keywords
- Deep Vein Thrombosis, anticoagulants, surgery, pulmonary embolus, warfarin, fondaparinox
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 7 Oct 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.
The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.
Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.
Detailed description
Inclusion Criteria:
- Planned for elective primary arthroplasty for knee and hip disease at New England Baptist Hospital.
- Over 20 years of age.
- Normal baseline platelet count, prothrombin and partial thromboplastin times.
- Signed consent.
Exclusion Criteria:
- Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- Patients with personal history of TED, or documented hypercoagulation disease.
- Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
SPECIFIC AIMS:
This prospective, randomized study seeks to determine if there is an advantage for fixed, low dose of warfarin Thromboembolic Disease (TED) prophylaxis among patients undergoing elective lower extremity joint arthroplasty, as compared to variable dose warfarin and a low molecular weight heparin (LMWH). If confirmed as effective fixed, low dose warfarin would be an almost ideal prophylaxis against Deep Vein Thrombosis (DVT) and Pulmonary Embolus (PE): inexpensive, easy to administer, with minimal hemorrhagic potential, needing minimal laboratory support .
BACKGROUND AND SIGNIFICANCE:
A progression of studies has been performed to examine the efficacy of low dose warfarin. These studies demonstrated that low dose warfarin has antithrombotic activity, with little anticoagulant effect. Critical to this approach that the warfarin therapy be initiated prior to surgery. A summary of other studies offering supportive or conflicting data is available. (1-9)
- Low dose warfarin (2mg) dampens activated coagulation. (1-3)
- Two-step low dose warfarin begun 10-14 days pre-op is effective prophylaxis. (4)
- Low dose warfarin (1mg) prevents DVT's surrounding central venous catheters when started 3 days before catheter insertion among patients at very high risk for subclavian DVT. (5,6)
- Low dose warfarin (1mg) started 7 days prior to surgery is equal to variable dose warfarin for TED prophylaxis following hip arthroplasty. (7)
- Low dose warfarin (1mg) started 7 days prior to surgery is effective TED prophylaxis for patients having hip replacement arthroplasties in retrospective study of 1003 patients. (8)
The sentinel study used a fixed low dose warfarin regimen given to patients at extreme risk for DVT. Patients requiring central venous catheters for chemotherapy for metastatic cancer participated in a randomized study of 0.0 mg vs.1.0 mg daily warfarin starting 3 days prior to catheter placement. Subclavian vein venograms were performed at the time of symptoms of subclavian vein DVT or after 90 days. When using this low dose warfarin schedule there was a reduction in the incidence of thrombosis from 37.5% to 9.5%. (p<0.05) Four patients acquired vitamin K-responsive prolongation of the PT due to concomitant advanced liver disease and/or malnutrition. Concentrations of factors II, VII, IX, X, and protein C showed no difference between treated and untreated patients. (5)
Two orthopedic surgery studies from NEBH on this question have been published. (7,8) The first was a pilot study of 100 patients demonstrated no difference between the effectiveness of low fixed dose and variable dose warfarin in a population of patients at high risk for TED (7) Patients studied were planning total hip replacement arthroplasty were randomized between the standard regimens using warfarin of 5 mg the night prior to surgery followed by variable dose (target PT 1.3 - 1.5 times normal) for 30-45 days, or the experimental regimen using 1 mg beginning 7 days prior to surgery and continued until follow up at 30-45 days. Ultrasounds of the deep veins of the legs were performed at baseline, at discharge following surgery, and at 30-45 day follow-up. There was no difference between the groups for incidence of venous thrombosis. The second study was a retrospective study of patients undergoing primary (833) or revision (170) hip replacement arthroplasty receiving 1 mg warfarin for 7 days before surgery, variable dose while in hospital, (INR target 1.5 - 2.0) followed by 1 mg daily until follow-up at 30-45 days. (8) Each patient used pneumatic followed by elastic compression stockings. Of these 1003 patients, with 9 lost to follow-up. Three patients had TED, including 1 PE and 2 DVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: warfarinVariable dose warfarin: 5 mg beginning the night before surgery, followed by 5mg the PM of surgery*, and then variable daily dose,until day 30 follow-up. (target INR 2.0-2.5) |
| 2 | Active comparator | Drug: Fondaparinux:Fondaparinux: 2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*,or 6-8 hours after epidural catheter removal, and continued until follow-up (28 days +/-2) from day of surgery. |
| 3 | Active comparator | Drug: warfarinFixed Low Dose warfarin 1 mg daily beginning 7 days preoperative, and continued at 1 mg daily follow-up at Day 28 (+/-2 days from surgery). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Planned for elective arthroplasty for knee and hip disease.
- Over 20 years of age.
- Normal baseline platelet count, prothrombin and partial thromboplastin times.
- Signed consent.
Key exclusion criteria (12 listed)
- Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- Patients with personal history of TED, or documented hypercoagulation disease.
- Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
- Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
- Liver enzymes or bilirubin greater than 2 x normal.
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 |
|---|---|---|
| warfarinAlso: Coumadin5 mg beginning the night before surgery, followed by 5 mg the PM of surgery*, and then variable daily dose, until day 28 (+/-2 days) from day of surgery follow-up. (target INR 2.0 -2.5) | Drug | 1 |
| Fondaparinux:Also: Arixtra2.5 mg daily starting more than 6 hours following surgery and no later than 6 AM the next day*, or 6-8 hours after epidural catheter removal, and continued until follow up day 28 (+/-2 days) from day of surgery. | Drug | 2 |
| warfarinAlso: coumadinFixed Low Dose warfarin 1 mg daily beginning 7 days preoperative, and continued at 1 mg daily until follow-up 28 day (+/- 2 days) from day of surgery. | Drug | 3 |
Primary outcome
Primary Outcome based upon intent to treat: Composite outcome of
Time frame: 28 days
Ultrasound or venogram confirmed deep vein thrombosis.
Time frame: 28 days
Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.
Time frame: 28 days
Death due to TED
Time frame: 28 days
10 secondary outcomes
Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures
Time frame: 28 days
Distribution of proximal vs distal deep vein thrombosis of the leg
Time frame: 28 days
Amount of intraoperative bleeding
Time frame: follow until Dec. 31, 2010
Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events.
Time frame: follow until Dec. 31, 2010
Number of ultrasounds and V/Q or CTA's required
Time frame: follow until Dec. 31, 2010
Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications
Time frame: follow until Dec. 31, 2010
Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit.
Time frame: follow until Dec. 31, 2010
Death due to any other cause than TED
Time frame: follow until Dec. 31, 2010
Use of low molecular weight dextran
Time frame: follow until Dec. 31, 2010
Use of nonsteroidal anti-inflammatory drugs
Time frame: follow until Dec. 31, 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
- Derived from this study: PubMed 26448724Bern MM, Hazel D, Deeran E, Richmond JR, Ward DM, Spitz DJ, Mattingly DA, Bono JV, Berezin RH, Hou L, Miley GB, Bierbaum BE. Low dose compared to variable dose Warfarin and to Fondaparinux as prophylaxis for thromboembolism after elective hip or knee replacement surgery; a randomized, prospective study. Thromb J. 2015 Oct 7;13:32. doi: 10.1186/s12959-015-0062-0. eCollection 2015.
- Derived from this study: PubMed 25975205Bern MM, Hazel D, Reilly DT, Adcock DM, Hou L. Effects of anticoagulation on markers of activation of clotting following major orthopedic surgery. Int J Lab Hematol. 2015 Oct;37(5):673-9. doi: 10.1111/ijlh.12384. Epub 2015 May 15.
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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.
Murray Bern, MD principal investigator
New England Baptist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing warfarin and Fondaparinux: in people with Pulmonary Embolism, run by The New England Baptist Hospital 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 26 Sep 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 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?
Results are not available in the source record.
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?
Primary Outcome based upon intent to treat: Composite outcome of (time frame: 28 days). The study lists 4 primary outcomes in all. 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 NCT00767559, 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 26 Sep 2011.