Back to resultsDesmopressin for Bleeding Related to Low Body Temperature
Primary Purpose
Hypothermia Induced Impairment of Primary Haemostasis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
desmopressin
desmopressin
desmopressin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia Induced Impairment of Primary Haemostasis
Eligibility Criteria
Inclusion Criteria:
1. Healthy volunteers
Exclusion Criteria:
- 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
Sites / Locations
- The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
desmopressin 1.5
desmopressin 3
desmopressin 15
placebo
Arm Description
Outcomes
Primary Outcome Measures
closure time on PFA-100
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00902057
Brief Title
Desmopressin for Bleeding Related to Low Body Temperature
Official Title
Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia Induced Impairment of Primary Haemostasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
desmopressin 1.5
Arm Type
Active Comparator
Arm Title
desmopressin 3
Arm Type
Active Comparator
Arm Title
desmopressin 15
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
desmopressin
Intervention Description
single desmopressin subcutaneous injection, 1.5mcg
Intervention Type
Drug
Intervention Name(s)
desmopressin
Intervention Description
single desmopressin subcutaneous injection, 3mcg
Intervention Type
Drug
Intervention Name(s)
desmopressin
Intervention Description
single desmopressin subcutaneous injection, 15mcg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
saline subcutaneous
Primary Outcome Measure Information:
Title
closure time on PFA-100
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1. Healthy volunteers
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kwok F.J. Ng, MBChB, MD, MBA, FANZCA, FHKAM
Phone
(852) 28553303
Email
jkfng@hku.hk
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
HKSAR
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwok F.J. Ng, MBChB, MD, FANZCA, FHKAM, MBA
Phone
(852) 28553303
Email
jkfng@hku.hk
First Name & Middle Initial & Last Name & Degree
Kwok F. J. Ng, MD,MBA
12. IPD Sharing Statement
Learn more about this trial
Desmopressin for Bleeding Related to Low Body Temperature
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