LBWH: The Effect of Heparinization Due to LBW

Sponsor

Adiyaman University Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03113708

Collaborator

(none)

Enrollment

Arms

1.7

Anticipated Duration (Months)

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Apr 30, 2017

Anticipated Primary Completion Date :

May 20, 2017

Anticipated Study Completion Date :

Jun 20, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

ACT [Through study completion, an average of 48 hours]
Activated clotting time

Secondary Outcome Measures

Bleeding [Through study completion, an average of 48 hours]
Postoperative bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Adiyaman University Research Hospital

Investigators

Principal Investigator: Ulku Sabuncu, Yuksek Ihtisas Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Ülkü Sabuncu, Medical Doctor, Adiyaman University Research Hospital

ClinicalTrials.gov Identifier:

NCT03113708

Other Study ID Numbers:

LBW heparin

First Posted:

Apr 13, 2017

Last Update Posted:

Apr 14, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. Ülkü Sabuncu, Medical Doctor, Adiyaman University Research Hospital

Additional relevant MeSH terms:

Drug Overdose

Heparin

Calcium heparin

Study Results

No Results Posted as of Apr 14, 2017