Intraoperative Blood LossPhase 3NCT01708642
The Effect of Administration of Low Dose Adrenaline During Surgery on Bleeding During Hip Surgery
A Phase 3 study testing Adrenaline in people with Intraoperative Blood Loss, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Blood Loss
- What is being tested?
- Adrenaline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 3 sitesDenmark
- Study dates
- Nov 2012to Sep 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Age > 18 years.
- Scheduled for primary unilateral hip arthroplasty
- Able to give consent
Who cannot join
- Allergy towards adrenaline
- Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
- Current treatment with tricyclic antidepressants
- Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
- Acute coronary syndrome / myocardial infarction within the previous 6 months.
- not willing to accept blood transfusion
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- Participation in other clinical trial within previous 30 days
- Women of childbearing age (without menopause for at least 12 months)
- Glaucoma
- Pheochromocytoma
- Low serum K+ (< 3.0 mmol/L)
- Thyrotoxicosis
- Digoxin intoxication
- Alcohol og drug abuse (investigators judgement)
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Gentofte Hospital, Department of Anaesthesia
Hellerup, 2900
Hvidovre Hospital, Department of orthopaedic surgery
Hvidovre, 2650
Vejle Sygehus, Department of orthopedic surgery
Vejle, 7100
About this study
Official title: The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial
The purpose of this study is to evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.
Read the detailed description
Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.
- Conditions
- Intraoperative Blood Loss
- Being tested
- Adrenaline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Also called Ephinephrine
Adrenaline infusion 0.05 microgram / kg / minute
PlaceboDrug
Intraoperative isotonic saline infusion as placebo for adrenaline.
| Study group | Role | What they receive |
|---|---|---|
| Adrenaline | Experimental | Intraoperative low-dose adrenaline infusion Receives: Drug: Adrenaline |
| Placebo | Placebo comparator | Placebo: Isotonic Saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Intraoperative blood loss as estimated from surgical drain and sponges.
Measured: End of surgery (last suture)
Secondary outcomes (1)
Calculated blood loss
Calculated blood loss at 24 h after end of surgery.
Measured: 24 hours after end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2013
- Study completionSep 2013
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 Intraoperative Blood LossStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oeivind Jans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pär I Johanssion, M.D., DMsc., Study chair, Rigshospitalet, Section for transfusion medicineOeivind Jans, M.D., Principal investigator, Rigshospitalet, Section for Surgical Pathophysiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708642
- Sponsor's protocol ID
- RH-4074-OJ2
- Other IDs
- 2012-002889-12
- Status last verified
- Feb 2015
- First submitted
- 15 Oct 2012
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jans O, Grevstad U, Mandoe H, Kehlet H, Johansson PI. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty. Br J Anaesth. 2016 Mar;116(3):357-62. doi: 10.1093/bja/aev408. Epub 2016 Jan 27.
PubMed 26821696
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Low Dose Adrenaline on Bleeding in Total Hip Arthroplasty - a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT01708642
- Acronym / sponsor ID
- RH-4074-OJ2
- Conditions
- Intraoperative Blood Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 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 evaluate the effect of intraoperative administration of low-dose adrenaline on intraoperative blood loss in patients undergoing hip surgery.
Detailed description
Hip arthroplasty is associated with bleeding, anemia and the need for allogeneic transfusion. Administration of low-dose adrenaline activates the coagulation system and may decrease intraoperative and immediate postoperative bleeding. Thus, the aim of this study is to evaluation whether intraoperative IV-administration of low-dose adrenaline reduces bleeding in elective total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenaline | Experimental | Drug: AdrenalineIntraoperative low-dose adrenaline infusion |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo: Isotonic Saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years.
- Scheduled for primary unilateral hip arthroplasty
- Able to give consent
Key exclusion criteria (14 listed)
- Allergy towards adrenaline
- Current treatment with: ADP receptor inhibitors or Vitamin K antagonists (within 5 days), Factor Xa inhibitors or Thrombin inhibitors (within 1 day), heparin (excluding low molecular weight heparin for perioperative thromboprophylaxis).
- Current treatment with tricyclic antidepressants
- Use of MAO inhibitors (within previous 14 days) or COMT inhibitors (within 2 days).
- Acute coronary syndrome / myocardial infarction within the previous 6 months.
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 |
|---|---|---|
| AdrenalineAlso: EphinephrineAdrenaline infusion 0.05 microgram / kg / minute | Drug | Adrenaline |
| PlaceboIntraoperative isotonic saline infusion as placebo for adrenaline. | Drug | Placebo |
Primary outcome
Intraoperative blood loss
Time frame: End of surgery (last suture)
Intraoperative blood loss as estimated from surgical drain and sponges.
1 secondary outcome
Calculated blood loss
Time frame: 24 hours after end of 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 18 Feb 2015.
- Derived from this study: PubMed 26821696Jans O, Grevstad U, Mandoe H, Kehlet H, Johansson PI. A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty. Br J Anaesth. 2016 Mar;116(3):357-62. doi: 10.1093/bja/aev408. Epub 2016 Jan 27.
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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.
Pär I Johanssion, M.D., DMsc. study chair
Rigshospitalet, Section for transfusion medicine
Oeivind Jans, M.D. principal investigator
Rigshospitalet, Section for Surgical Pathophysiology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adrenaline in people with Intraoperative Blood Loss, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
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 14 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 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Intraoperative blood loss (time frame: End of surgery (last suture)). 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 NCT01708642, 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 18 Feb 2015.