- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03113708
The Effect of Heparinization Due to LBW (LBWH)
April 13, 2017 updated by: Dr. Ülkü Sabuncu, Adiyaman University Research Hospital
The Effect of Heparinization Due to LBW in Cardiac Surgery
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ulku Sabuncu, M.D.
- Phone Number: +90 533 708 5212
- Email: sabuncuulku@gmail.com
Study Contact Backup
- Name: Aslihan Aykut, M.D.
- Phone Number: +90 532 550 2013
- Email: asli_dncr@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-65 years old, first time valve surgeries which was done on-pump.
Exclusion Criteria:
- Revision valve surgeries
- Patients with coagulation deficits
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACT
Time Frame: Through study completion, an average of 48 hours
|
Activated clotting time
|
Through study completion, an average of 48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bleeding
Time Frame: Through study completion, an average of 48 hours
|
Postoperative bleeding
|
Through study completion, an average of 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ulku Sabuncu, Yuksek Ihtisas Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 30, 2017
Primary Completion (Anticipated)
May 20, 2017
Study Completion (Anticipated)
June 20, 2017
Study Registration Dates
First Submitted
March 25, 2017
First Submitted That Met QC Criteria
April 10, 2017
First Posted (Actual)
April 13, 2017
Study Record Updates
Last Update Posted (Actual)
April 14, 2017
Last Update Submitted That Met QC Criteria
April 13, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LBW heparin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bleeding
-
Ethicon, Inc.Guangzhou Bioseal Biotechnology Co., Ltd.Completed
-
Waihong ChungUnknownMetoclopramide, Azithromycin, or Nondrug Pretreatment for UGIB to Reduce Second Endoscopy (MANPURSE)Upper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Ottawa Hospital Research InstituteRecruitingGastroIntestinal Bleeding | Anticoagulant-induced BleedingCanada
-
Ethicon, Inc.CompletedHemorrhage | Soft Tissue Bleeding | Hepatic Parenchyma BleedingUnited Kingdom, Belgium
-
Hyloris DevelopmentsRecruitingBleeding From Teeth | Bleeding ProphylaxisSpain, United States, Belgium, Croatia, Hungary, Romania
-
Boston Children's HospitalBaylor College of Medicine; Children's Hospital of Philadelphia; Ann & Robert... and other collaboratorsRecruitingUpper Gastrointestinal Bleeding | Gastro Intestinal BleedingUnited States
-
Wake Forest University Health SciencesCompletedBleeding ComplicationUnited States
-
Chinese University of Hong KongCompletedGastrointestinal Bleeding | Bleeding Peptic Ulcer | Active BleedingChina
-
Chinese University of Hong KongBeijing Friendship Hospital; The First Affiliated Hospital of Soochow University and other collaboratorsCompletedAcute Upper Gastrointestinal Bleeding | Tumor BleedingHong Kong, China, Australia
-
Women and Infants Hospital of Rhode IslandActive, not recruitingAbnormal Uterine Bleeding | Abnormal Uterine Bleeding, Ovulatory Dysfunction | Abnormal Uterine Bleeding, Endometrial Hemostatic DysfunctionUnited States
Clinical Trials on Heparin Sodium
-
Azidus BrasilUnknown
-
Azidus BrasilCompleted
-
Azidus BrasilUnknownCardiac SurgeryBrazil
-
Eurofarma Laboratorios S.A.TerminatedHip Fracture SurgeryBrazil
-
Azidus BrasilUnknownVenous ThromboembolismBrazil
-
Azidus BrasilWithdrawnVenous Thromboembolism