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Clinical Trials/NCT03113708
NCT03113708
Unknown
Phase 4

The Effect of Heparinization Due to LBW in Cardiac Surgery

Adiyaman University Research Hospital0 sites50 target enrollmentApril 30, 2017

Overview

Phase
Phase 4
Intervention
Heparin Sodium
Conditions
Heparin
Sponsor
Adiyaman University Research Hospital
Enrollment
50
Primary Endpoint
ACT
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2017
End Date
June 20, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Adiyaman University Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr. Ülkü Sabuncu

Medical Doctor

Adiyaman University Research Hospital

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

Arms & Interventions

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.

Intervention: Heparin Sodium

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.

Intervention: Heparin Sodium

Outcomes

Primary Outcomes

ACT

Time Frame: Through study completion, an average of 48 hours

Activated clotting time

Secondary Outcomes

  • Bleeding(Through study completion, an average of 48 hours)

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