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The Effect of Heparinization Due to LBW (LBWH)

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ClinicalTrials.gov Identifier: NCT03113708
Recruitment Status : Unknown
Verified April 2017 by Dr. Ülkü Sabuncu, Adiyaman University Research Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 13, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Ülkü Sabuncu, Adiyaman University Research Hospital

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.

Condition or disease Intervention/treatment Phase
Heparin Heparin Overdose Bleeding Drug: Heparin Sodium Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Closed envelope
Primary Purpose: Diagnostic
Official Title: The Effect of Heparinization Due to LBW in Cardiac Surgery
Estimated Study Start Date : April 30, 2017
Estimated Primary Completion Date : May 20, 2017
Estimated Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Heparinisation,actual body weight
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 2-4 mg/kg will be done according to actual body weight or lean body weight.

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




Primary Outcome Measures :
  1. ACT [ Time Frame: Through study completion, an average of 48 hours ]
    Activated clotting time


Secondary Outcome Measures :
  1. Bleeding [ Time Frame: Through study completion, an average of 48 hours ]
    Postoperative bleeding



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113708


Contacts
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Contact: Ulku Sabuncu, M.D. +90 533 708 5212 sabuncuulku@gmail.com
Contact: Aslihan Aykut, M.D. +90 532 550 2013 asli_dncr@hotmail.com

Sponsors and Collaborators
Adiyaman University Research Hospital
Investigators
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Principal Investigator: Ulku Sabuncu Yuksek Ihtisas Hospital

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Responsible Party: Dr. Ülkü Sabuncu, Medical Doctor, Adiyaman University Research Hospital
ClinicalTrials.gov Identifier: NCT03113708     History of Changes
Other Study ID Numbers: LBW heparin
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Dr. Ülkü Sabuncu, Adiyaman University Research Hospital:
heparin
heparin antagonists
cardiac surgery
active clotting time
Additional relevant MeSH terms:
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Hemorrhage
Drug Overdose
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action