Patients Undergoing Endoscopic Sinus SurgeryPhase 4NCT02125188
Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
A Phase 4 study testing Desmopressin and saline in people with Patients Undergoing Endoscopic Sinus Surgery, run by Tao Zhang at 1 site in China.
Trial summary
Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons and anesthesiologists despite several measures available for improving the surgical field. This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patients Undergoing Endoscopic Sinus Surgery
- What is being tested?
- Desmopressin and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Aug 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I-II
- aged 18-60 years
Who cannot join
- Patients receiving anticoagulants
- medically important liver or kidney dysfunction
- significant heart disease
- allergy to Desmopressin
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
About this study
Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons and anesthesiologists despite several measures available for improving the surgical field. This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS.
Read the detailed description
Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional treatment for hemophilia and von Willebrand's disease. Hemostatic effects of desmopressin include: 1) an increase in plasma factors through endogenous release of coagulation factor VIII, von Willebrand factor and tissue plasminogen activator; 2) an increase in platelet adhesiveness; and 3) a reduction in bleeding time. Randomized, double-blind studies have been performed on patients undergoing various types of surgical procedures. A study in patients undergoing orthognathic surgery showed a significant reduction in intraoperative blood loss and a study in patients undergoing lumbar fusion concluded that desmopressin was effective in reducing intraoperative blood loss. The purpose of this study was to investigate the effect of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.
- Being tested
- Desmopressin, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Desmopressin 3ug/kg ivdrip before surgery
salineDrug
saline 100ml ivdrip before surgery
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Desmopressin 3ug/kg in saline 100ml ivdrip before surgery Receives: Drug: Desmopressin |
| saline | Placebo comparator | saline 100ml ivdrip before surgery Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
Measured: During Functional Endoscopic Sinus Surgery of each patient
Secondary outcomes (1)
Quality of the surgical field using a scoring scale
The overall quality of the surgical field was assessed on a scoring scale adapted from Boezaart et al. The following are the scoring scale:
0-1: No bleeding; excellent to outstanding surgical conditions; 2-3: Slight bleeding; surgery fairly easy. No stops for hemostasis and/or suctioning are required; 4-5: Slight bleeding; surgery mildly difficult. One stop for hemostasis and/or suctioning is required; 6-7: Moderate bleeding; surgery moderately difficult. Occasional stops for hemostasis and/or suctioning are required; 8-9: Moderate to severe bleeding; surgery very difficult. Multiple stops for hemostasis and/or suctioning are required; 10: Surgery terminated due to severe bleeding in the surgical field.
Measured: During Functional Endoscopic Sinus Surgery of each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Endoscopic Sinus SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tao Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tao Zhang, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125188
- Sponsor's protocol ID
- desmopressinFESS
- Status last verified
- Jun 2017
- First submitted
- 21 Apr 2014
- Last updated
- 6 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Desmopressin on Blood Loss and the Quality of the Surgical Field During Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT02125188
- Acronym / sponsor ID
- desmopressinFESS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tao ZhangUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Apr 2014 (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.
Bleeding during functional endoscopic sinus surgery (FESS) is a challenge for both surgeons and anesthesiologists despite several measures available for improving the surgical field. This study was conducted to evaluate the effect of desmopressin on blood loss and the quality of the surgical field in FESS.
Detailed description
Desmopressin, a synthetic analogue of vasopressin, has been employed as a non-transfusional treatment for hemophilia and von Willebrand's disease. Hemostatic effects of desmopressin include: 1) an increase in plasma factors through endogenous release of coagulation factor VIII, von Willebrand factor and tissue plasminogen activator; 2) an increase in platelet adhesiveness; and 3) a reduction in bleeding time. Randomized, double-blind studies have been performed on patients undergoing various types of surgical procedures. A study in patients undergoing orthognathic surgery showed a significant reduction in intraoperative blood loss and a study in patients undergoing lumbar fusion concluded that desmopressin was effective in reducing intraoperative blood loss. The purpose of this study was to investigate the effect of administration of desmopressin on intraoperative blood loss in patients undergoing FESS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmopressinDesmopressin 3ug/kg in saline 100ml ivdrip before surgery |
| saline | Placebo comparator | Drug: salinesaline 100ml ivdrip before surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I-II
- aged 18-60 years
Key exclusion criteria (4 listed)
- Patients receiving anticoagulants
- medically important liver or kidney dysfunction
- significant heart disease
- allergy to Desmopressin
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 |
|---|---|---|
| DesmopressinDesmopressin 3ug/kg ivdrip before surgery | Drug | Desmopressin |
| salinesaline 100ml ivdrip before surgery | Drug | saline |
Primary outcome
Blood loss
Time frame: During Functional Endoscopic Sinus Surgery of each patient
1 secondary outcome
Quality of the surgical field using a scoring scale
Time frame: During Functional Endoscopic Sinus Surgery of each patient
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 6 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and saline in people with Patients Undergoing Endoscopic Sinus Surgery, run by Tao Zhang at 1 site in China.
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 4 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 6 Jun 2017. 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 China. 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?
Blood loss (time frame: During Functional Endoscopic Sinus Surgery of each patient). 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 6 Jun 2017.