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Hemostatic Effect of Various Colloid Solutions

NCT00518544 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2007-08-20

No results posted yet for this study

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).

Conditions

  • Laminectomy

Interventions

DRUG

administration of hydroxyehtyl starch

colloid is administered during operation according to blood loss.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Hyun Joo Ahn, MD., PhD. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00518544 on ClinicalTrials.gov