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Clinical Trials/NCT00902057
NCT00902057
Unknown
Phase 4

Effect of Desmopressin on Platelet Dysfunction Associated With Mild Hypothermia in Healthy Volunteers

The University of Hong Kong1 site in 1 country48 target enrollmentStarted: June 2009Last updated:

Overview

Phase
Phase 4
Enrollment
48
Locations
1
Primary Endpoint
closure time on PFA-100

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Arms & Interventions

desmopressin 1.5

Active Comparator

Intervention: desmopressin (Drug)

desmopressin 3

Active Comparator

Intervention: desmopressin (Drug)

desmopressin 15

Active Comparator

Intervention: desmopressin (Drug)

placebo

Placebo Comparator

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

closure time on PFA-100

Time Frame: 3 hours

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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