Comparison Between Colloids and Crystalloids on Coagulation and Blood Loss

NCT06683079 | Completed

• 1 other identifier: colloids versus crystalloids
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Infusion of intravenous fluids is mandatory especially in major and prolonged surgeries. However, there is no available optimum ideal type of fluid nor a fixed amount suitable for transfusion but it must be individualized for every patient to minimize the side effects of fluids. Ringer's lactate as an example of crystalloids, causes a transient hypercoagulable state after its infusion, disappears in less than 6 hours of infusion and the coagulation profile returns to its state before Ringer's. Voluven (Hydroxyehthyl starch 130/0.4) a colloid causes a hypocoagulable state after its infusion, and its effect is prolonged to more than 6 hours after infusion. The effects of hydroxyethyl starch are not dose-dependent, but they can be remarkable even with mild to moderate amount of blood dilution applying nearly a restrictive fluid transfusion strategy and a goal-directed fluid therapy mode. The amount of needed crystalloids is much more than that of colloids to maintain patients hemodynamically stable.

Conditions

Coagulopathy

Outcome Measures

Primary Outcomes (7)

• Prothrombin Time (PT) Measurement

  Measurement of Prothrombin Time to assess the effect of colloid and crystalloid administration on clotting time. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  Baseline just after induction, at end of infusion, and 6 hours post-operative.

• International Normalized Ratio (INR)

  Calculation of International Normalized Ratio to standardize clotting time measurements and evaluate the effect of fluid type on coagulation. Unit of Measure: ratio. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  baseline just after induction, at end of infusion, 6 hours post-operative.

• Activated Partial Thromboplastin Time (aPTT)

  Measurement of Activated Partial Thromboplastin Time to assess the intrinsic coagulation pathway after administration of colloid or crystalloid. Unit of Measure: seconds. Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  baseline just after induction, at end of infusion, 6 hours post-operative.

• Factor V Levels

  Measurement of plasma levels of coagulation Factor V to evaluate changes in coagulation function following fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  baseline just after induction, at end of infusion, 6 hours post-operative.

• Factor VIII Levels

  Plasma level measurement of coagulation Factor VIII to assess the impact of colloid and crystalloid on coagulation. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  Baseline just after induction, at end of infusion, 6 hours post-operative.

• Factor IX Levels

  Measurement of coagulation Factor IX levels in plasma to assess any changes in the clotting profile after fluid administration. Unit of Measure: International Units per deciliter (IU/dL). Measurement Tool: laboratory tests were all supplied by technology of Marburg, Germany using Sysmex Cs 2100i, code (THL-02) with serial number 22880.

  Baseline just after induction, at end of infusion, 6 hours post-operative.

• Blood Loss Volume

  Measurement of total blood loss volume to compare the effects of colloid and crystalloid solutions on hemostasis. Blood loss is calculated using the method outlined by Choi et al. (2010), which includes the volume in suction (minus irrigation fluid), visible blood on the surgical field, and blood absorbed in surgical pads. Surgical pads are estimated by inspection, with fully soaked pads counted as 150 mL and half-soaked pads as 100 mL. Unit of Measure: milliliters (mL).

  Total volume recorded at the end of the surgical procedure.

Secondary Outcomes (1)

• Blood transfusion requirements

  Total units required recorded at the end of the surgical procedure.

Study Arms (2)

colloid group

recieve colloids as a maintenance intraoperative fluid .

crystalloid group

recieve crystalloids as a maintenance intraoperative fluid .

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient undergoing elective colorectal surgery

You may qualify if:

• age between 18 to 75 years
• undergoing elective colorectal surgery

You may not qualify if:

• refusal by the patient
• patient with cardiac disease
• hepatic disease
• renal disease
• blood disease
• patient on regular anticoagulant drug

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Kilany Ali Abdelsalam

  Supervisor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: November 12, 2024
• Study Start: September 15, 2017
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)