Arthritis of the HipPhase 4NCT01714297
Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)
A Phase 4 study testing dalteparin 5000 IU s.c. in people with Arthritis of the Hip and Transfusion Related Complications, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthritis of the Hip, Transfusion Related Complications, Infection
- What is being tested?
- dalteparin 5000 IU s.c.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Apr 2009
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis
Who cannot join
- allergy to Low-Molecular-Weight -Heparin
- bleeding disorders
- renal failure
- hepatic disease
- active treatment for malignancy
- history of deep venous thrombosis or pulmonary embolism
- major operations,trauma,stroke or cardiac infarction the last 3 months before surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin
The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.
- Being tested
- dalteparin 5000 IU s.c.
- Keywords
- cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers
- Medical subject headings
- Infections, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalteparin 5000 IU s.c.Drug
Also called Fragmin
All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.
| Study group | Role | What they receive |
|---|---|---|
| dalteparin 5000IU s.c. | Active comparator | 5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty Receives: Drug: dalteparin 5000 IU s.c. |
| saline | Placebo comparator | Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days Receives: Drug: dalteparin 5000 IU s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
total blood loss
measured blood loss during surgery and in wound drains
Measured: during and after surgery
Secondary outcomes (3)
transfusion requirements
number of units packed red blood cells
Measured: during and after surgery
incidence of bleeding events
excessive bleeding, wound hematoma, wound secretion, other bleeding events
Measured: during and after surgery
other complications
all other complications related to surgery
Measured: during and after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionApr 2009
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 Arthritis of the HipStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Pål Borgen, MD, Vestre Viken Hospital Trust
- Investigators
- Olav Reikeras, MD, Phd, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714297
- Sponsor's protocol ID
- REK Sør-øst s-08012d
- Status last verified
- Dec 2012
- First submitted
- 23 Oct 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.
PubMed 22476844
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Double Blind Study to Evaluate Safety and Effect With Pre Versus Postoperative Start of Thromboprophylaxis With Dalteparin
- ClinicalTrials.gov ID
- NCT01714297
- Acronym / sponsor ID
- REK Sør-øst s-08012d
- Keywords
- cemented total hip arthroplasty, blood loss, wound discharge, thromboprophylaxis, biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 25 Oct 2012 (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 study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalteparin 5000IU s.c. | Active comparator | Drug: dalteparin 5000 IU s.c.5000IU dalteparin s.c. injected the evening before cemented total hip arthroplasty |
| saline | Placebo comparator | Drug: dalteparin 5000 IU s.c.Syringes of Saline with the same volume as in the dalteparin injections are injected the evenings before total hip arthroplasty. Dalteparin 5000IU are injected 6 hours after surgery and the concomitant 33 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -patients 50 years or older undergoing cemented total hip arthroplasty for primary osteoarthritis
Key exclusion criteria (7 listed)
- allergy to Low-Molecular-Weight -Heparin
- bleeding disorders
- renal failure
- hepatic disease
- active treatment for malignancy
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 |
|---|---|---|
| dalteparin 5000 IU s.c.Also: FragminAll patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35. | Drug | dalteparin 5000IU s.c., saline |
Primary outcome
total blood loss
Time frame: during and after surgery
measured blood loss during surgery and in wound drains
3 secondary outcomes
transfusion requirements
Time frame: during and after surgery
incidence of bleeding events
Time frame: during and after surgery
other complications
Time frame: during and after 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 10 Dec 2012.
- Results publication: PubMed 22476844Borgen PO, Dahl OE, Reikeras O. Blood loss in cemented THA is not reduced with postoperative versus preoperative start of thromboprophylaxis. Clin Orthop Relat Res. 2012 Sep;470(9):2591-8. doi: 10.1007/s11999-012-2320-9. Epub 2012 Apr 3.
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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.
Olav Reikeras, MD, Phd study chair
Oslo University Hospital
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 testing dalteparin 5000 IU s.c. in people with Arthritis of the Hip and Transfusion Related Complications, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 10 Dec 2012. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
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?
total blood loss (time frame: during and after surgery). 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 NCT01714297, 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 10 Dec 2012.