- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00518544
Hemostatic Effect of Various Colloid Solutions
Hemostatic Effect of Various Colloid Solutions According to Blood Types
Background: Individuals with type O blood have reduced factor VIII and von Willebrand factor levels compared to the non-O counterpart. Infusion of hydroxyethyl starch (HES) impairs coagulation and, in O blood type, apparent coagulopathy can develop after HES infusion. A newly market-released balanced HES (670/0.75) has physiologic pH and balanced electrolytes including calcium, which are beneficial to coagulation. Studies comparing balanced HES (670/0.75) with saline-based HES (130/0.4), previously known the least coagulopathic are rare. Therefore, we try to reveal the difference of coagulation, pH/electrolyte balance, and bleeding amount between the non-O and O blood types after infusion of these two newest HES.
Methods: Each 20 of non-O and type O ASA 1 or 2 patients scheduled for spinal surgery involving 2 or 3 spinal levels were enrolled. 20 ml/kg of saline-based HES (130/0.4) or balanced HES (670/0.75) was administered during operation. Blood loss, coagulation and metabolic profiles were checked at pre-infusion (T0), 5 min after infusion (T1), 4 hrs after infusion (T2) and 24 hrs after infusion (T4).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyun Joo Ahn, MD., PhD.
- Phone Number: 82-2-3410-0784
- Email: hjahn@smc.samsung.co.kr
Study Locations
-
-
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Seoul, Korea, Republic of, 135-710
- Recruiting
- Samsung Medical Center
-
Contact:
- Hyun Joo Ahn, MD.,PhD.
- Phone Number: 82-2-3410-0784
- Email: hjahn@smc.samsung.co.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.
Exclusion Criteria:
- the presence of cardiovascular diseases, cerebral vascular disease, hepatic, pulmonary, or renal disease, hemoglobin < 12 g/dl, platelet count < 150,000 /ml, coagulopathy, taking medication likely to alter coagulation less than 2 weeks before the study, or an allergic reaction to HES
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood loss, coagulation and metabolic profiles
Time Frame: pre-infusion, 5 min after infusion, 4 hrs after infusion
|
pre-infusion, 5 min after infusion, 4 hrs after infusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyun Joo Ahn, MD., PhD., Samsung Medical Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CRS107-17-1
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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