Hypothermia Induced Impairment of Primary HaemostasisPhase 4NCT00902057
Desmopressin for Bleeding Related to Low Body Temperature
A Phase 4 study testing desmopressin in people with Hypothermia Induced Impairment of Primary Haemostasis, run by The University of Hong Kong at 1 site in China.
Trial summary
To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia Induced Impairment of Primary Haemostasis
- 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
- 48 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Jun 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy volunteers
Who cannot join
- Any known platelet or coagulation disorder.
- Pregnant or lactating women.
- Known chronic liver or renal disease.
- Coronary artery, carotid artery or peripheral artery disease
- Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
- Smoker or alcohol user
- Mentally incapable of providing informed consent
- Students or junior staff members who had direct working relationship with the PI
Trial locations and contacts
1 site in 1 country.
China1 site
The University of Hong Kong
Hong Kong, Hong Kong, HKSAR
Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, MBA, (852) 28553303, jkfng@hku.hk
Kwok F. J. Ng, MD,MBA
About this study
Official title: Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.
- Being tested
- desmopressin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desmopressinDrug
single desmopressin subcutaneous injection, 1.5mcg
desmopressinDrug
single desmopressin subcutaneous injection, 3mcg
desmopressinDrug
single desmopressin subcutaneous injection, 15mcg
placeboDrug
saline subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| desmopressin 1.5 | Active comparator | Not described Receives: Drug: desmopressin |
| desmopressin 3 | Active comparator | Not described Receives: Drug: desmopressin |
| desmopressin 15 | Active comparator | Not described Receives: Drug: desmopressin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
closure time on PFA-100
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothermia Induced Impairment of Primary HaemostasisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902057
- Sponsor's protocol ID
- UW 09-088
- Status last verified
- May 2009
- First submitted
- 13 May 2009
- Last updated
- 14 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00902057
- Acronym / sponsor ID
- UW 09-088
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 14 May 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.
To study, with a prospective randomised controlled design, whether the subcutaneous administration of the haemostatic drug desmopressin, may improve the impairment of primary haemostasis due to mildly decreased temperature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| desmopressin 1.5 | Active comparator | Drug: desmopressin |
| desmopressin 3 | Active comparator | Drug: desmopressin |
| desmopressin 15 | Active comparator | Drug: desmopressin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy volunteers
Key exclusion criteria (8 listed)
- Any known platelet or coagulation disorder.
- Pregnant or lactating women.
- Known chronic liver or renal disease.
- Coronary artery, carotid artery or peripheral artery disease
- Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
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 |
|---|---|---|
| desmopressinsingle desmopressin subcutaneous injection, 1.5mcg | Drug | desmopressin 1.5 |
| desmopressinsingle desmopressin subcutaneous injection, 3mcg | Drug | desmopressin 3 |
| desmopressinsingle desmopressin subcutaneous injection, 15mcg | Drug | desmopressin 15 |
| placebosaline subcutaneous | Drug | placebo |
Primary outcome
closure time on PFA-100
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2009.
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.
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 Hypothermia Induced Impairment of Primary Haemostasis, run by The University of Hong Kong 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 1 inclusion and 8 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 14 May 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM ((852) 28553303, jkfng@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
closure time on PFA-100 (time frame: 3 hours). 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 14 May 2009.