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The Effect of Heparinization Due to LBW (LBWH)

Primary Purpose

Heparin, Heparin Overdose, Bleeding

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Heparin Sodium
Sponsored by
Adiyaman University Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heparin focused on measuring heparin, heparin antagonists, cardiac surgery, active clotting time

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-65 years old, first time valve surgeries which was done on-pump.

Exclusion Criteria:

  • Revision valve surgeries
  • Patients with coagulation deficits

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Heparinisation,actual body weight

    Heparinisation, lean body weight

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    ACT
    Activated clotting time

    Secondary Outcome Measures

    Bleeding
    Postoperative bleeding

    Full Information

    First Posted
    March 25, 2017
    Last Updated
    April 13, 2017
    Sponsor
    Adiyaman University Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03113708
    Brief Title
    The Effect of Heparinization Due to LBW
    Acronym
    LBWH
    Official Title
    The Effect of Heparinization Due to LBW in Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 30, 2017 (Anticipated)
    Primary Completion Date
    May 20, 2017 (Anticipated)
    Study Completion Date
    June 20, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Adiyaman University Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Patients with preoperative demographic data such as age, gender, body weight, height, and additional disease, medications, previous surgery, preoperative Htc / Hb values were recorded in the operation room without medical premedication. Standard anesthesia induction was performed after arterial cannulation and peripheral venous route. Patients were randomly divided into two groups: 400 IU heparin / kg (Group I) and 400 IU heparin / kg (Group II) according to actual body weight and lean body weight respectively before CPB. Before and after heparin administration, CPB entry and ACT (Activated Clotting Time) values were counted every 30 minutes, after CPB exit and protamine. In both groups, supplemental heparin was administered when there was a failure to reach the pre-CPB target ACT value of 400 sec. Hemodynamic data and transfusion requirements were recorded during the operation. Patient's intraoperative CPB and crossover times, postoperative drainage volume and blood transfusion requirement were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heparin, Heparin Overdose, Bleeding
    Keywords
    heparin, heparin antagonists, cardiac surgery, active clotting time

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    Closed envelope
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Heparinisation,actual body weight
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Arm Title
    Heparinisation, lean body weight
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin Sodium
    Intervention Description
    Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.
    Primary Outcome Measure Information:
    Title
    ACT
    Description
    Activated clotting time
    Time Frame
    Through study completion, an average of 48 hours
    Secondary Outcome Measure Information:
    Title
    Bleeding
    Description
    Postoperative bleeding
    Time Frame
    Through study completion, an average of 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18-65 years old, first time valve surgeries which was done on-pump. Exclusion Criteria: Revision valve surgeries Patients with coagulation deficits
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ulku Sabuncu, M.D.
    Phone
    +90 533 708 5212
    Email
    sabuncuulku@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aslihan Aykut, M.D.
    Phone
    +90 532 550 2013
    Email
    asli_dncr@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ulku Sabuncu
    Organizational Affiliation
    Yuksek Ihtisas Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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