NCT03113708

Brief Summary

High dose heparin regimens are required in cardiac surgery under cardiopulmonary bypass (CPB) and this may increase postoperative bleeding. The aim of this study is to evaluate the effect of heparin dose calculated according to lean body weight on intraoperative and postoperative bleeding.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

March 25, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

April 30, 2017

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

20 days

First QC Date

March 25, 2017

Last Update Submit

April 13, 2017

Conditions

HeparinHeparin OverdoseBleeding

Keywords

heparinheparin antagonistscardiac surgeryactive clotting time

Outcome Measures

Primary Outcomes (1)

  • ACT

    Activated clotting time

    Through study completion, an average of 48 hours

Secondary Outcomes (1)

  • Bleeding

    Through study completion, an average of 48 hours

Study Arms (2)

Heparinisation,actual body weight

SHAM COMPARATOR

In 'Heparinisation,actual body weight' group , heparin sodium; will be done according to actual body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.

Drug: Heparin Sodium

Heparinisation, lean body weight

EXPERIMENTAL

In 'Heparinisation, lean body weight' group heparin sodium will be done according to lean body weight and ACT will be recorded prior to CPB. Before coming out CPB, protamine will be done according to heparin dose. And then ACT will be recorded.

Drug: Heparin Sodium

Interventions

Heparin SodiumDRUG

Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.

Heparinisation, lean body weightHeparinisation,actual body weight

Eligibility Criteria

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

You may qualify if:

  • years old, first time valve surgeries which was done on-pump.

You may not qualify if:

  • Revision valve surgeries
  • Patients with coagulation deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ulku Sabuncu

    Yuksek Ihtisas Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulku Sabuncu, M.D.

CONTACT

+90 533 708 5212sabuncuulku@gmail.com

Aslihan Aykut, M.D.

CONTACT

+90 532 550 2013asli_dncr@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Closed envelope
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 25, 2017

First Posted

April 13, 2017

Study Start

April 30, 2017

Primary Completion

May 20, 2017

Study Completion

June 20, 2017

Last Updated

April 14, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share