Desmopressin for Bleeding Related to Low Body Temperature

May 13, 2009 updated by: The University of Hong Kong

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, HKSAR
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Healthy volunteers

Exclusion Criteria:

  1. Any known platelet or coagulation disorder.
  2. Pregnant or lactating women.
  3. Known chronic liver or renal disease.
  4. Coronary artery, carotid artery or peripheral artery disease
  5. Recent history of taking antiplatelet drugs, anticoagulants or herbal preparations.
  6. Smoker or alcohol user
  7. Mentally incapable of providing informed consent
  8. Students or junior staff members who had direct working relationship with the PI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
saline subcutaneous
Active Comparator: desmopressin 1.5
Drug: desmopressin
single desmopressin subcutaneous injection, 1.5mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 3mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 15mcg
Active Comparator: desmopressin 3
Drug: desmopressin
single desmopressin subcutaneous injection, 1.5mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 3mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 15mcg
Active Comparator: desmopressin 15
Drug: desmopressin
single desmopressin subcutaneous injection, 1.5mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 3mcg
Drug: desmopressin
single desmopressin subcutaneous injection, 15mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
closure time on PFA-100
Time Frame: 3 hours
3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

May 13, 2009

First Submitted That Met QC Criteria

May 13, 2009

First Posted (Estimate)

May 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 14, 2009

Last Update Submitted That Met QC Criteria

May 13, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW 09-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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