HemorrhagePhase 4NCT00885924
Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
A Phase 4 study testing Desmopressin in people with Hemorrhage and Postoperative Blood Loss, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Postoperative Blood Loss
- What is being tested?
- Desmopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Feb 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age scheduled for cardiac surgery
- Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours
Who cannot join
- Patients younger than 18 years of age
- Patients with a medical condition known to influence the hemostatic system
- Patients treated with clopidogrel or systemic steroids during the last week before surgery
- Patients with INR above 1.5
- Patients who are not able to give written informed concent
- Unstable patients who need other transfusion limits than in this study
Trial locations and contacts
1 site in 1 country.
About this study
Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.
- Conditions
- Hemorrhage, Postoperative Blood Loss
- Being tested
- Desmopressin, Placebo
- Keywords
- postoperative Hemorrhage, Hemorrhage, Vasopressin, Blood Loss, Surgical
- Medical subject headings
- Hemorrhage, Postoperative Hemorrhage, Diabetes Insipidus, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called Octostim, Ferring ATC-nr.:H01B A02
Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min.
PlaceboDrug
NaCl 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Desmopressin 0.3 microgram/kg Receives: Drug: Desmopressin |
| Placebo | Placebo comparator | NaCl 0.9% Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion of blood components
Measured: During postoperative stay
Secondary outcomes (3)
Postoperative hemorrhage
Measured: First 16 hours postoperatively
Platelet activation
Measured: 20 hours postoperatively
Activation of coagulation
Measured: 20 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: to include required number of patients took too much time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guri Greiff, MD, Principal investigator, StOalvs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885924
- Sponsor's protocol ID
- 4.2008.947
- Status last verified
- Apr 2015
- First submitted
- 2 Apr 2009
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desmopressin as Treatment for Postoperative Bleeding After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00885924
- Acronym / sponsor ID
- 4.2008.947
- Conditions
- Hemorrhage, Postoperative Blood Loss
- Keywords
- postoperative Hemorrhage, Hemorrhage, Vasopressin, Blood Loss, Surgical
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: to include required number of patients took too much time
- Enrolment
- 17 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Apr 2009 (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.
Some patients undergoing cardiac surgery develop excessive postoperative bleeding. Cardiopulmonary bypass causes platelet dysfunction. Several studies have documented the ability of desmopressin to reduce hemorrhage in a variety of congenital and acquired platelet disorders. In this study the investigators will investigate wether desmopressin reduces postoperative microvascular bleeding. The investigators will investigate wether desmopressin reduces platelet activation as measured by plasma concentration of neutrophil activating peptid 2 and by flow cytometry. The primary endpoint of the study will, however, be total postoperative bleeding and need for transfusions of blood components after surgery. The need for transfusions will be registered during the whole hospital stay. Patient with excessive postoperative bleeding (more than 250 ml for one hour, or more than 150ml for two hours during the first four hours) will be randomized into two groups and given either desmopressin or placebo (0,9% sodium chloride) as an intravenous infusion. Blood samples for plasma concentration measurements will be drawn before infusion of desmopressin/placebo, immediately after the infusion and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Drug: DesmopressinDesmopressin 0.3 microgram/kg |
| Placebo | Placebo comparator | Drug: PlaceboNaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 18 years of age scheduled for cardiac surgery
- Excessive postoperative bleeding, more than 250 ml for one hour, or more than 150ml for two hours during the first four hours
Key exclusion criteria (6 listed)
- Patients younger than 18 years of age
- Patients with a medical condition known to influence the hemostatic system
- Patients treated with clopidogrel or systemic steroids during the last week before surgery
- Patients with INR above 1.5
- Patients who are not able to give written informed concent
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 |
|---|---|---|
| DesmopressinAlso: Octostim, Ferring ATC-nr.:H01B A02Desmopressin 0.3 microgram/kg as an intravenous infusion given during 20 min. | Drug | Active treatment |
| PlaceboNaCl 0.9% | Drug | Placebo |
Primary outcome
Transfusion of blood components
Time frame: During postoperative stay
3 secondary outcomes
Postoperative hemorrhage
Time frame: First 16 hours postoperatively
Platelet activation
Time frame: 20 hours postoperatively
Activation of coagulation
Time frame: 20 hours postoperatively
Results and safety
The study was stopped early (reason given: to include required number of patients took too much time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Guri Greiff, MD principal investigator
StOalvs 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 Desmopressin in people with Hemorrhage and Postoperative Blood Loss, run by St. Olavs Hospital 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Apr 2015. 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 was stopped early (reason given: to include required number of patients took too much time). 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?
Transfusion of blood components (time frame: During postoperative stay). 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 8 Apr 2015.