NCT00518544

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).

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
Last Updated

August 20, 2007

Status Verified

August 1, 2007

First QC Date

August 16, 2007

Last Update Submit

August 16, 2007

Conditions

Laminectomy

Keywords

hydroxyethyl starch, blood type, coagulation

Outcome Measures

Primary Outcomes (1)

  • Blood loss, coagulation and metabolic profiles

    pre-infusion, 5 min after infusion, 4 hrs after infusion

Interventions

administration of hydroxyehtyl starchDRUG

colloid is administered during operation according to blood loss.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of ASA 1 or 2, and scheduled for posterior laminectomy and internal fixation at two or three spinal levels.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung medical center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Hyun Joo Ahn, MD., PhD.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Joo Ahn, MD., PhD.

CONTACT

82-2-3410-0784hjahn@smc.samsung.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

July 1, 2007

Last Updated

August 20, 2007

Record last verified: 2007-08

Locations

KR(1)