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Hemostatic Effect of Various Colloid Solutions

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ClinicalTrials.gov Identifier: NCT00518544
Recruitment Status : Unknown
Verified August 2007 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : August 20, 2007
Last Update Posted : August 20, 2007
Information provided by:
Samsung Medical Center

Brief Summary:

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).

Condition or disease Intervention/treatment
Laminectomy Drug: administration of hydroxyehtyl starch

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Hemostatic Effect of Various Colloid Solutions According to Blood Types
Study Start Date : July 2007

Intervention Details:
    Drug: administration of hydroxyehtyl starch
    colloid is administered during operation according to blood loss.

Primary Outcome Measures :
  1. Blood loss, coagulation and metabolic profiles [ Time Frame: pre-infusion, 5 min after infusion, 4 hrs after infusion ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518544

Contact: Hyun Joo Ahn, MD., PhD. 82-2-3410-0784 hjahn@smc.samsung.co.kr

Korea, Republic of
Samsung medical center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Hyun Joo Ahn, MD.,PhD.    82-2-3410-0784    hjahn@smc.samsung.co.kr   
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Hyun Joo Ahn, MD., PhD. Samsung Medical Center

ClinicalTrials.gov Identifier: NCT00518544     History of Changes
Other Study ID Numbers: CRS107-17-1
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: August 20, 2007
Last Verified: August 2007

Keywords provided by Samsung Medical Center:
hydroxyethyl starch, blood type, coagulation

Additional relevant MeSH terms: