Hemostatic Effect of Various Colloid Solutions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00518544
First received: August 16, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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 Intervention
Laminectomy
Drug: administration of hydroxyehtyl starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Hemostatic Effect of Various Colloid Solutions According to Blood Types

Further study details as provided by Samsung Medical Center:

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

Study Start Date: July 2007
Intervention Details:
    Drug: administration of hydroxyehtyl starch
    colloid is administered during operation according to blood loss.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518544

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

Locations
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
Investigators
Principal Investigator: Hyun Joo Ahn, MD., PhD. Samsung Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00518544     History of Changes
Other Study ID Numbers: CRS107-17-1
Study First Received: August 16, 2007
Last Updated: August 16, 2007
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014